64 Lead Pharmaceutical Regulatory Affairs Specialist Remote jobs in Kenya
Lead Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
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Job Description
Our client, a leading name in the pharmaceutical industry, is actively seeking a highly experienced and detail-oriented Lead Pharmaceutical Regulatory Affairs Specialist. This is a fully remote role, allowing you to contribute from any location in Kenya. You will be instrumental in ensuring our pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. This position demands a deep understanding of drug development, submission processes, and post-approval maintenance.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to relevant health authorities.
- Monitor and interpret changes in pharmaceutical regulations and guidelines, providing proactive guidance to the organization.
- Liaise effectively with regulatory agencies, health authorities, and other stakeholders.
- Oversee the regulatory aspects of product lifecycle management, including variations, renewals, and amendments.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Provide regulatory input and support for product development, clinical trials, and marketing authorization applications.
- Manage regulatory documentation and databases, ensuring accuracy and completeness.
- Lead and mentor junior regulatory affairs professionals, fostering a collaborative and expert team environment.
- Conduct regulatory intelligence activities to stay abreast of evolving global regulatory landscapes.
Qualifications:
- Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, KEBS).
- Proven experience in preparing and submitting marketing authorization applications.
- Demonstrated experience managing regulatory submissions for various therapeutic areas.
- Excellent understanding of drug development processes and regulatory pathways.
- Strong analytical, problem-solving, and project management skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Experience working in a remote or hybrid team setting is highly desirable.
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Remote Lead Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
Job Viewed
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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Senior Risk Analyst, Regulatory Compliance
Posted 19 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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Remote Aviation Regulatory Compliance Specialist
Posted 17 days ago
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Job Description
Our client, a forward-thinking aviation organization, is seeking a knowledgeable and meticulous Remote Aviation Regulatory Compliance Specialist. This fully remote role is crucial for ensuring that all operations, policies, and procedures adhere to national and international aviation regulations. You will be responsible for monitoring regulatory changes, conducting internal audits, and developing compliance strategies to maintain the highest standards of safety and operational integrity. This position requires a deep understanding of aviation law and compliance frameworks.
Responsibilities:
Qualifications:
Responsibilities:
- Monitor and interpret aviation regulations from authorities such as EASA, FAA, and local civil aviation bodies.
- Develop, implement, and maintain comprehensive compliance programs and policies.
- Conduct regular internal audits and assessments to ensure adherence to regulations.
- Identify potential compliance risks and develop mitigation strategies.
- Prepare and submit necessary documentation and reports to regulatory agencies.
- Advise management and operational teams on regulatory requirements and best practices.
- Stay current with all legislative changes and industry standards impacting aviation operations.
- Investigate and manage compliance-related issues and incidents.
- Develop and deliver training on regulatory compliance to relevant personnel.
- Maintain accurate records of all compliance activities and documentation.
Qualifications:
- Extensive experience in aviation regulatory compliance, aviation law, or a related field.
- In-depth knowledge of national and international aviation regulations (e.g., EASA, FAA, ICAO).
- Strong analytical skills with the ability to interpret complex legal and regulatory documents.
- Excellent written and verbal communication skills.
- Proven ability to develop and implement compliance policies and procedures.
- Experience in conducting audits and risk assessments.
- High level of integrity and attention to detail.
- Ability to work independently and manage responsibilities effectively in a remote setting.
- A Bachelor's degree in Law, Aviation Management, or a related field is required; a Master's degree is a plus.
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Lead Regulatory Compliance Attorney
Posted 12 days ago
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Job Description
Our client is seeking a seasoned and highly experienced Lead Regulatory Compliance Attorney to ensure adherence to all legal and regulatory requirements. This is a fully remote position, offering the flexibility to manage compliance initiatives and advise the organization from anywhere. You will be responsible for interpreting complex regulations, developing and implementing compliance programs, and overseeing internal audits to ensure adherence to standards across various jurisdictions. The ideal candidate will possess a comprehensive understanding of regulatory frameworks relevant to our client's industry, strong analytical skills, and the ability to translate legal requirements into actionable business processes. Your responsibilities will include staying abreast of legislative changes, advising on potential compliance risks, developing training materials for employees, and managing relationships with regulatory bodies. You will also lead investigations into potential compliance breaches and recommend appropriate corrective actions. This role requires exceptional legal acumen, meticulous attention to detail, and outstanding communication skills to effectively articulate compliance strategies and requirements to both legal and non-legal stakeholders. The ability to work autonomously, manage multiple projects simultaneously, and drive a culture of compliance within a remote setting is paramount. This is a crucial position that offers the opportunity to shape and safeguard the legal integrity of the organization, contributing significantly to its sustained success and reputation. We are looking for an attorney with a proven track record in regulatory compliance, exceptional problem-solving capabilities, and a dedication to upholding the highest ethical standards in a dynamic and evolving legal landscape. Your expertise will be vital in navigating the complexities of the regulatory environment and ensuring robust adherence to all applicable laws and standards.
Responsibilities:
Responsibilities:
- Develop and implement comprehensive regulatory compliance programs.
- Interpret and advise on complex legal and regulatory requirements.
- Conduct internal audits and assessments to ensure compliance.
- Stay current with changes in legislation and regulatory frameworks.
- Develop and deliver compliance training to employees.
- Manage relationships with regulatory agencies and authorities.
- Investigate potential compliance violations and recommend corrective actions.
- Advise senior management on compliance risks and strategies.
- Draft and review compliance-related policies and procedures.
- Ensure ethical conduct and integrity across the organization.
- Juris Doctor (JD) or equivalent law degree.
- Admission to the bar and in good standing.
- Minimum of 8 years of experience focused on regulatory compliance, preferably in-house or at a reputable law firm.
- Deep understanding of relevant industry regulations (e.g., financial services, data privacy, environmental).
- Proven experience in developing and implementing compliance programs.
- Excellent analytical, research, and problem-solving skills.
- Strong negotiation and communication abilities, with the capacity to influence stakeholders.
- Demonstrated ability to manage complex projects and lead teams remotely.
This advertiser has chosen not to accept applicants from your region.
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Lead Regulatory Compliance Counsel
Posted 19 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and knowledgeable Lead Regulatory Compliance Counsel to guide their legal and compliance functions. This is a fully remote position, offering the flexibility to manage complex regulatory matters from anywhere within Kenya. You will be responsible for ensuring that the company adheres to all relevant local and international laws, regulations, and industry standards. This includes developing, implementing, and monitoring compliance programs, conducting risk assessments, and providing expert legal advice on regulatory issues. The ideal candidate will have a comprehensive understanding of compliance frameworks, a strong track record in navigating regulatory landscapes, and exceptional analytical and problem-solving skills. You will lead a team of compliance professionals, mentor junior staff, and work closely with various departments to foster a culture of compliance throughout the organization. Key responsibilities include drafting and reviewing compliance policies, overseeing internal investigations, managing regulatory audits and inquiries, and staying abreast of evolving regulatory requirements. This role demands strategic thinking, impeccable judgment, and the ability to communicate complex legal and regulatory concepts clearly to diverse audiences. If you are a seasoned legal professional with a passion for compliance and seeking a challenging and impactful remote leadership role, we encourage you to apply.
Responsibilities:
Responsibilities:
- Develop, implement, and manage comprehensive regulatory compliance programs.
- Ensure adherence to all applicable laws, regulations, and industry standards.
- Conduct regular compliance risk assessments and develop mitigation strategies.
- Draft, review, and update compliance policies, procedures, and guidelines.
- Oversee internal investigations and respond to regulatory inquiries and audits.
- Provide expert legal counsel on regulatory matters to all levels of the organization.
- Lead and mentor a team of compliance officers and legal professionals.
- Stay informed about changes in regulations and advise on their impact.
- Promote a strong culture of compliance and ethical conduct.
- Liaise with external legal counsel and regulatory bodies as needed.
- Manage reporting requirements to regulatory agencies.
- Juris Doctor (J.D.) or equivalent law degree from a reputable institution.
- Admitted as an Advocate of the High Court of Kenya with a current practicing certificate.
- Minimum of 10 years of experience in regulatory compliance, with a significant portion in a legal counsel role.
- Proven experience in developing and implementing compliance programs within a corporate environment.
- Deep understanding of relevant industry-specific regulations and legal frameworks.
- Exceptional analytical, research, and problem-solving skills.
- Strong leadership, team management, and interpersonal abilities.
- Excellent written and verbal communication skills, with the ability to articulate complex legal concepts.
- High ethical standards and integrity.
- Ability to work independently, manage multiple priorities, and lead effectively in a remote setting.
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Senior Regulatory Compliance Counsel
Posted 5 days ago
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Job Description
Our client, a respected firm in the legal sector, is seeking an experienced and detail-oriented Senior Regulatory Compliance Counsel to join their fully remote legal team. This crucial role involves providing expert legal advice and guidance on a wide range of regulatory compliance matters. The Senior Counsel will be responsible for interpreting and applying complex legal and regulatory requirements across various jurisdictions relevant to our client's business operations. Key duties include developing, implementing, and maintaining robust compliance programs and policies, conducting compliance training for employees, and advising on the legal implications of new business initiatives. You will also be involved in responding to regulatory inquiries, managing internal investigations, and overseeing the legal aspects of audits and examinations. The ideal candidate will have a strong understanding of corporate law, regulatory frameworks, and best practices in compliance. Exceptional analytical, research, and drafting skills are essential. This is a remote-first position, requiring a self-starter with excellent time management and organizational abilities, capable of managing a demanding workload independently. Strong interpersonal and communication skills are vital for collaborating effectively with internal teams and external stakeholders in a virtual environment. Membership in good standing with the relevant bar association is mandatory. A Juris Doctor (JD) or equivalent law degree, with at least 6-8 years of post-qualification experience focusing on regulatory compliance, corporate governance, or a related field, is required. Experience within a law firm or in-house legal department, preferably with exposure to the financial services or technology sectors, would be a significant asset. This position offers the opportunity to shape compliance strategies and contribute significantly to our client's commitment to ethical and lawful business conduct, all while working remotely.
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7
Senior In-House Counsel - Regulatory Compliance
Posted 20 days ago
Job Viewed
Job Description
Our client, a rapidly expanding enterprise, is seeking a seasoned Senior In-House Counsel with extensive expertise in regulatory compliance to join their fully remote legal department. This critical role will involve advising on and ensuring adherence to a wide array of local and international regulations relevant to our client's operations. The successful candidate will be proactive in identifying potential compliance risks and developing robust strategies to mitigate them. This position requires a deep understanding of legal frameworks, excellent analytical skills, and the ability to communicate complex legal concepts to non-legal stakeholders.
Responsibilities:
Qualifications:
This is a fully remote opportunity, offering the flexibility to work from anywhere. Our client values diversity and inclusion.
Responsibilities:
- Develop, implement, and maintain comprehensive compliance programs across all business units.
- Interpret and advise on the application of relevant laws and regulations, including data privacy, consumer protection, anti-bribery, and industry-specific rules.
- Conduct regular compliance audits and risk assessments to identify areas of potential non-compliance.
- Develop and deliver compliance training programs for employees at all levels.
- Investigate compliance concerns and allegations of misconduct, recommending appropriate corrective actions.
- Liaise with regulatory authorities, government agencies, and external counsel on compliance matters.
- Draft and review corporate policies and procedures to ensure alignment with legal and regulatory requirements.
- Stay abreast of changes in the regulatory landscape and advise the business on their impact.
- Manage and oversee legal aspects of government investigations and inquiries.
- Contribute to the development of strategies to enhance the company's compliance culture.
- Provide legal support for new product launches and business initiatives, ensuring regulatory considerations are addressed.
- Maintain accurate records of compliance activities and regulatory filings.
Qualifications:
- Juris Doctor (J.D.) or equivalent law degree from an accredited institution.
- Active license to practice law in a relevant jurisdiction.
- Minimum of 7 years of experience practicing in regulatory compliance, corporate law, or as in-house counsel, preferably within a regulated industry.
- Demonstrated expertise in one or more key compliance areas (e.g., GDPR, CCPA, FCPA, KYC, AML).
- Proven experience in developing and implementing compliance programs.
- Excellent analytical, problem-solving, and risk management skills.
- Strong negotiation and advocacy abilities.
- Exceptional written and verbal communication skills, with the ability to explain complex legal issues clearly.
- Ability to work independently, manage a demanding workload, and prioritize effectively in a remote environment.
- Experience interacting with regulatory bodies is highly advantageous.
- High ethical standards and a commitment to professional integrity.
This is a fully remote opportunity, offering the flexibility to work from anywhere. Our client values diversity and inclusion.
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Senior Corporate Counsel, Regulatory Compliance
Posted 20 days ago
Job Viewed
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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