753 Remote Pharmaceutical Regulatory Affairs Specialist jobs in Kenya
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
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Job Description
Our client is seeking a detail-oriented and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their dynamic team in a fully remote capacity. This vital role involves ensuring compliance with all relevant pharmaceutical regulations and guidelines throughout the product lifecycle, from development to post-market surveillance. You will be responsible for preparing and submitting regulatory documentation, liaising with regulatory agencies, and staying abreast of evolving regulatory requirements. The ideal candidate will possess a strong understanding of pharmaceutical drug development, regulatory processes, and international regulatory frameworks. Key responsibilities include managing regulatory submissions (e.g., INDs, NDAs, MAAs), reviewing product labeling for compliance, assessing changes to approved products, and providing regulatory guidance to internal teams. You will also be involved in regulatory strategy development and risk assessment. Experience with specific therapeutic areas or drug classes is advantageous. This is an exceptional opportunity to make a significant contribution to patient access to safe and effective medicines, working from a remote environment with a leading pharmaceutical organization. You must possess excellent analytical, organizational, and communication skills, with a keen eye for detail. The ability to interpret complex regulations and apply them effectively to specific situations is crucial. A bachelor's or master's degree in a relevant scientific field (e.g., Pharmacy, Chemistry, Biology) is required. This role demands a proactive approach, the ability to work independently, and strong collaboration skills to work effectively with cross-functional teams. The conceptual work location is **Mlolongo, Machakos, KE**, but the position is performed entirely remotely.
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Principal Remote Pharmaceutical Regulatory Affairs Specialist
Posted 16 days ago
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Job Description
Our client is actively seeking a highly accomplished and strategic Principal Remote Pharmaceutical Regulatory Affairs Specialist to navigate the complex landscape of pharmaceutical regulations worldwide. This is a fully remote position, offering the flexibility to influence global regulatory strategies from your home office. The successful candidate will be responsible for developing and executing comprehensive regulatory affairs strategies for the company's pharmaceutical products. This involves preparing, reviewing, and submitting regulatory documentation to health authorities in various regions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). You will stay abreast of evolving global regulatory requirements, guidelines, and trends, ensuring the company remains compliant and competitive. A significant aspect of this role involves providing expert regulatory guidance to cross-functional teams, including R&D, clinical affairs, manufacturing, and marketing, to ensure alignment with regulatory objectives. You will manage regulatory submissions throughout their lifecycle, responding to queries from health authorities and facilitating product approvals. The Principal Specialist will also play a key role in assessing the regulatory implications of product development, post-market changes, and lifecycle management activities. This position requires a deep understanding of pharmaceutical sciences, drug development processes, and international regulatory frameworks. Exceptional analytical, problem-solving, and project management skills are essential. Strong written and verbal communication abilities are critical for effective interaction with regulatory agencies and internal stakeholders in a remote setting. The ability to lead and influence teams, manage multiple projects simultaneously, and work independently with a high degree of accuracy is paramount. Experience in dossier preparation using common technical document (CTD) formats and proficiency with regulatory information management systems are highly desirable. This is an exceptional opportunity to shape the regulatory path of innovative medicines and contribute significantly to global health initiatives, working remotely near Thika, Kiambu, KE .
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Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
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Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to join their dedicated team. This fully remote role is crucial for navigating the complex regulatory landscape and ensuring compliance with global pharmaceutical standards. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and advising on regulatory strategies to support product development and market approval. The ideal candidate possesses a strong understanding of pharmaceutical regulations, meticulous attention to detail, and proven success in a remote work setting.
Responsibilities:
Responsibilities:
- Prepare, review, and submit regulatory dossiers for drug applications (e.g., IND, NDA, MAA) to relevant health authorities.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines.
- Liaise directly with regulatory agencies (e.g., FDA, EMA, local health authorities) to facilitate the review process and respond to queries.
- Develop and implement global regulatory strategies to support product development and lifecycle management.
- Monitor and interpret changes in regulatory requirements and provide timely updates and recommendations to internal teams.
- Assess the regulatory impact of product changes, manufacturing processes, and promotional materials.
- Collaborate closely with R&D, Quality Assurance, Clinical Operations, and Commercial teams to ensure regulatory requirements are met.
- Maintain regulatory databases and ensure the accuracy and completeness of regulatory documentation.
- Provide regulatory training and guidance to internal stakeholders.
- Conduct regulatory intelligence activities to stay ahead of evolving requirements.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience working effectively in a remote capacity, managing regulatory submissions and communications from a distance.
- In-depth knowledge of global pharmaceutical regulatory requirements and submission processes (e.g., ICH guidelines).
- Proven experience in preparing and submitting various types of regulatory filings.
- Excellent written and verbal communication skills, with a strong ability to articulate complex regulatory information clearly.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Proficiency in regulatory information management systems (RIMS) and document management systems.
- Ability to work independently, manage multiple priorities, and meet strict deadlines.
- Experience with a variety of therapeutic areas is a plus.
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Remote Lead Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
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Job Description
Our client is seeking a highly accomplished and strategically-minded Lead Pharmaceutical Regulatory Affairs Specialist to guide their global regulatory strategy. This is a pivotal, fully remote leadership role demanding extensive experience in navigating complex pharmaceutical regulations across diverse international markets. You will be responsible for developing and executing regulatory submission plans, ensuring compliance with health authority requirements (e.g., FDA, EMA, local agencies), and managing all aspects of regulatory filings for new drug applications, variations, and post-approval changes. Your expertise will be crucial in interpreting regulatory guidelines, providing strategic advice to R&D and commercial teams, and ensuring that all product development and marketing activities align with current regulatory standards. Key responsibilities include leading regulatory team efforts, conducting regulatory intelligence gathering, preparing and reviewing regulatory documents, and serving as the primary liaison with regulatory agencies. The ideal candidate will possess a deep understanding of the pharmaceutical drug lifecycle, clinical development, and manufacturing processes, coupled with a proven track record in successful regulatory submissions and approvals. Exceptional analytical, communication, and negotiation skills are essential for effectively collaborating with internal stakeholders and external regulatory bodies. This role requires a proactive approach to identifying regulatory risks and opportunities, and the ability to develop innovative solutions to regulatory challenges. You will mentor and develop regulatory affairs professionals, fostering a culture of compliance and excellence. This is a unique opportunity to make a significant impact on global drug development and patient access to essential medicines, all within a flexible, fully remote work environment. We are seeking a seasoned regulatory expert with a visionary outlook and the ability to lead and inspire a remote team towards achieving critical regulatory milestones.
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Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
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Job Description
Our client is seeking a highly experienced and knowledgeable Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote position. You will be responsible for ensuring that our pharmaceutical products comply with all relevant national and international regulatory requirements throughout their lifecycle. This critical role involves developing and executing regulatory strategies, preparing submission dossiers, and liaising with health authorities to secure product approvals and maintain compliance. The ideal candidate will possess a deep understanding of pharmaceutical regulations, guidelines, and submission processes across key markets. Your expertise will be vital in interpreting complex regulatory requirements, advising product development teams, and ensuring timely and successful submissions. Responsibilities include preparing and reviewing regulatory documentation, managing post-approval variations, and staying abreast of evolving regulatory landscapes. You will collaborate closely with R&D, clinical affairs, quality assurance, and commercial teams, virtually, to achieve regulatory objectives. Exceptional analytical, communication, and project management skills are essential for success in this role, enabling effective navigation of the regulatory environment and seamless collaboration within a remote setting. This is an excellent opportunity to contribute to bringing life-saving medicines to patients worldwide.
Responsibilities:
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities.
- Act as the primary point of contact with regulatory agencies, responding to queries and facilitating communication.
- Ensure compliance with all applicable pharmaceutical regulations, guidelines, and standards.
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Assess the regulatory implications of product changes, manufacturing processes, and clinical trial data.
- Advise project teams on regulatory requirements and strategies throughout the product development process.
- Review and approve labeling, promotional materials, and advertising for regulatory compliance.
- Stay current with global regulatory intelligence, trends, and policy changes.
- Contribute to the development of internal SOPs and quality systems related to regulatory affairs.
- Manage relationships with external consultants and regulatory service providers.
- Ensure accurate and timely maintenance of regulatory documentation and databases.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, Japan).
- In-depth knowledge of ICH guidelines and specific regional regulatory requirements.
- Experience with various dosage forms and therapeutic areas is advantageous.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proficiency in regulatory information management systems.
- Strong analytical and problem-solving abilities.
- Demonstrated ability to manage multiple projects and meet strict deadlines in a remote environment.
- Ability to work independently and collaboratively within cross-functional teams.
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Senior Regulatory Affairs Specialist - Pharmaceuticals - Remote
Posted 9 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Regulatory Affairs Specialist to join their globally distributed team. This is a crucial, fully remote position focused on ensuring compliance with pharmaceutical regulations across various international markets. You will be responsible for developing and executing regulatory strategies for product approvals, managing submissions, and maintaining regulatory compliance throughout the product lifecycle. Your expertise will guide the company through complex regulatory landscapes, ensuring timely market access for innovative therapies. Key responsibilities include preparing and submitting marketing authorization applications (MAAs), responding to regulatory agency queries, and staying abreast of evolving regulatory requirements. You will collaborate closely with R&D, clinical, manufacturing, and commercial teams to ensure regulatory alignment and success. The ideal candidate possesses a deep understanding of pharmaceutical regulations, strong analytical skills, and the ability to navigate diverse regulatory frameworks.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement global regulatory strategies for new drug applications and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD format) for marketing authorization applications (MAAs) in various regions.
- Serve as the primary liaison with regulatory authorities, responding to agency inquiries and facilitating communication.
- Ensure ongoing compliance with post-approval regulatory commitments and reporting requirements.
- Monitor and interpret changes in the global regulatory landscape and assess their impact on the company's product portfolio.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing.
- Evaluate regulatory risks and opportunities associated with product development and commercialization.
- Manage variations and amendments to approved marketing authorizations.
- Contribute to the development of regulatory policies and procedures.
- Conduct regulatory intelligence activities to identify emerging trends and competitor strategies.
- Mentor and train junior regulatory affairs professionals.
Qualifications:
- Master's degree or Ph.D. in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting MAAs in major markets (e.g., EMA, FDA, PPB).
- Thorough understanding of ICH guidelines and regional pharmaceutical regulatory requirements.
- Excellent scientific, analytical, and problem-solving skills.
- Exceptional written and verbal communication skills, with strong attention to detail.
- Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines.
- Proficiency in regulatory information management systems and electronic submission platforms.
- Strong interpersonal skills and the ability to collaborate effectively with internal teams and external stakeholders.
- Experience working effectively in a remote, international team environment.
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5
Senior Risk Analyst, Regulatory Compliance
Posted 18 days ago
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Job Description
Our client, a rapidly growing international financial institution, is actively recruiting a Senior Risk Analyst with a focus on regulatory compliance. This is a fully remote position, offering a flexible work environment to manage complex risk portfolios. You will be responsible for identifying, assessing, and mitigating a broad spectrum of financial risks, ensuring adherence to stringent regulatory frameworks and internal policies. This includes developing and implementing robust risk management frameworks, conducting comprehensive risk assessments, and monitoring key risk indicators. You will analyze financial data, market trends, and operational processes to detect potential vulnerabilities and propose effective mitigation strategies. The role requires a deep understanding of banking regulations, anti-money laundering (AML) requirements, know-your-customer (KYC) procedures, and capital adequacy directives. You will prepare detailed risk reports for senior management and regulatory bodies, ensuring clarity and accuracy. Collaboration with legal, compliance, and business units across the organization will be essential to foster a strong risk-aware culture. The ability to interpret complex regulatory documents and translate them into actionable business processes is crucial. You will also be involved in developing and delivering risk management training programs to employees. This is an exceptional opportunity for a seasoned risk professional to make a significant contribution to a leading financial services organization, working remotely from any location, but supporting operations connected to Bungoma, Bungoma, KE .
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Lead Environmental Lawyer, Regulatory Compliance
Posted 18 days ago
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Job Description
Our client is seeking a highly experienced Lead Environmental Lawyer to champion their regulatory compliance and sustainability initiatives. This is a fully remote position, allowing you to provide expert legal counsel on environmental matters from anywhere. You will be responsible for interpreting and applying complex environmental laws and regulations, advising on compliance strategies, and managing environmental legal risks for the organization. This role involves close collaboration with internal teams, external counsel, and regulatory bodies. The ideal candidate possesses a deep understanding of national and international environmental legislation, strong analytical and problem-solving skills, and the ability to navigate intricate legal landscapes.
Key responsibilities include:
The successful candidate will hold a Bachelor of Laws (LLB) degree and a Post Graduate Diploma in Legal Practice, with at least 7 years of post-admission experience specializing in environmental law. Proven experience in regulatory compliance, environmental litigation, and transactional environmental work is essential. Strong research, writing, and advocacy skills are required. The ability to manage multiple priorities and work effectively in a remote, collaborative environment is crucial. This is an excellent opportunity to make a significant impact on environmental stewardship within a forward-thinking organization, supporting operations near Malindi, Kilifi, KE .
Key responsibilities include:
- Providing expert legal advice on all aspects of environmental law and regulations relevant to the company's operations.
- Ensuring the company's compliance with environmental permits, licenses, and reporting requirements.
- Developing and implementing environmental compliance policies and procedures.
- Reviewing and advising on environmental impact assessments (EIAs) and related documentation.
- Representing the company in legal proceedings, administrative hearings, and negotiations with regulatory agencies.
- Assisting in the management of environmental liabilities and remediation efforts.
- Staying abreast of evolving environmental legislation, case law, and policy changes.
- Conducting legal research and providing analysis on emerging environmental issues.
- Advising on sustainable business practices and corporate social responsibility initiatives.
- Collaborating with engineering, operations, and EHS (Environment, Health, and Safety) teams to mitigate environmental risks.
The successful candidate will hold a Bachelor of Laws (LLB) degree and a Post Graduate Diploma in Legal Practice, with at least 7 years of post-admission experience specializing in environmental law. Proven experience in regulatory compliance, environmental litigation, and transactional environmental work is essential. Strong research, writing, and advocacy skills are required. The ability to manage multiple priorities and work effectively in a remote, collaborative environment is crucial. This is an excellent opportunity to make a significant impact on environmental stewardship within a forward-thinking organization, supporting operations near Malindi, Kilifi, KE .
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7
Senior Corporate Counsel, Regulatory Compliance
Posted 19 days ago
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Job Description
Our client is seeking a highly experienced and self-motivated Senior Corporate Counsel specializing in Regulatory Compliance to join their dynamic, remote-first legal team. This pivotal role will be instrumental in ensuring the company operates in full adherence to all relevant national and international laws and regulations across its diverse business units. You will be responsible for developing, implementing, and managing comprehensive compliance programs, conducting risk assessments, and advising senior management on potential legal and regulatory challenges. Key responsibilities include drafting and reviewing corporate policies, engaging with regulatory bodies, managing internal investigations, and staying abreast of evolving legal landscapes. The ideal candidate will possess exceptional analytical and problem-solving skills, a keen eye for detail, and the ability to translate complex legal concepts into actionable business strategies. You will work collaboratively with cross-functional teams, including operations, finance, and product development, to embed a culture of compliance throughout the organization. This is a unique opportunity to make a significant impact from a remote location, contributing to the ethical and sustainable growth of a forward-thinking company. A strong understanding of corporate governance, data privacy laws (e.g., GDPR, POPIA), anti-bribery and corruption legislation, and industry-specific regulations is essential. The ability to manage multiple priorities in a fast-paced environment and excellent communication skills are paramount. If you are a results-oriented legal professional with a passion for compliance and a desire to work in a fully remote setting, we encourage you to apply.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain robust compliance policies and procedures.
- Conduct regular compliance training for employees at all levels.
- Monitor and interpret changes in relevant laws and regulations.
- Manage and respond to regulatory inquiries and audits.
- Oversee internal investigations into potential compliance breaches.
- Advise on legal and compliance implications of new business initiatives.
- Collaborate with internal stakeholders to ensure best practices are adopted.
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admitted to practice law in Kenya or a recognized jurisdiction.
- Minimum of 7 years of experience in corporate law with a strong focus on regulatory compliance.
- Proven track record in developing and implementing compliance programs.
- In-depth knowledge of Kenyan and international regulatory frameworks.
- Excellent written and verbal communication skills.
- Proficiency in legal research and analysis.
- Ability to work independently and manage time effectively in a remote setting.
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Remote Corporate Counsel - Regulatory Compliance
Posted 19 days ago
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Job Description
Our client is seeking a highly motivated and experienced Remote Corporate Counsel specializing in regulatory compliance to join their expanding legal team. This critical role involves providing expert legal guidance on a wide range of regulatory matters, ensuring the company operates in full compliance with all applicable laws and regulations. You will be responsible for interpreting complex legal statutes, developing internal policies and procedures, advising on risk mitigation strategies, and managing regulatory inquiries and investigations. The ideal candidate possesses a sharp legal mind, exceptional analytical skills, and a proven ability to navigate the intricacies of corporate law in a remote setting.
Responsibilities:
Qualifications:
This is a fully remote position, allowing you to work from anywhere within Kenya. The scope of regulatory oversight will encompass operations related to **Embu, Embu, KE**.
Responsibilities:
- Provide comprehensive legal advice and counsel on all matters related to regulatory compliance, including industry-specific regulations, data privacy, and corporate governance.
- Interpret and analyze new legislation and regulatory changes, assessing their impact on the company's operations and business strategy.
- Develop, implement, and maintain robust compliance policies, procedures, and training programs for employees.
- Conduct internal investigations and audits to identify potential compliance breaches and recommend corrective actions.
- Manage regulatory inquiries, examinations, and enforcement actions, liaising effectively with government agencies and external counsel.
- Advise on risk assessment and mitigation strategies to proactively address potential legal and compliance issues.
- Review and draft contracts, agreements, and other legal documents, ensuring compliance with relevant laws.
- Stay abreast of legal developments and best practices in corporate law and regulatory compliance.
- Collaborate with internal stakeholders across various departments to ensure a unified approach to compliance.
- Prepare legal opinions, memos, and reports for senior management.
- Maintain accurate and organized legal records and documentation.
Qualifications:
- Juris Doctor (JD) or equivalent law degree from a recognized institution.
- Admission to the bar and good standing in Kenya.
- Minimum of 5 years of relevant experience in corporate law, with a strong emphasis on regulatory compliance.
- In-depth knowledge of Kenyan corporate law and regulatory frameworks.
- Proven experience in advising on data privacy regulations (e.g., GDPR principles if applicable), anti-corruption laws, and other relevant compliance areas.
- Exceptional analytical, research, and problem-solving skills.
- Excellent written and verbal communication and interpersonal skills.
- Ability to work independently, manage a demanding workload, and meet deadlines in a remote environment.
- Proficiency in legal research databases and standard office software.
- Experience working with multinational corporations is a plus.
- High ethical standards and professional integrity.
This is a fully remote position, allowing you to work from anywhere within Kenya. The scope of regulatory oversight will encompass operations related to **Embu, Embu, KE**.
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