153 Pharmaceutical Regulatory Affairs Manager jobs in Kenya
Pharmaceutical Regulatory Affairs Manager
Posted 20 days ago
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Job Description
Our client, a leading pharmaceutical company, is actively seeking a seasoned Pharmaceutical Regulatory Affairs Manager to lead their remote regulatory strategy. This senior role is critical for ensuring compliance with global regulatory requirements for drug development, approval, and post-market surveillance. You will be responsible for developing and implementing comprehensive regulatory submission strategies, preparing and filing dossiers with health authorities worldwide, and maintaining ongoing communication with regulatory agencies. Key responsibilities include providing regulatory guidance throughout the product lifecycle, assessing regulatory risks and opportunities, and ensuring adherence to cGMP, GCP, and GLP guidelines. The ideal candidate possesses a deep understanding of pharmaceutical product development, clinical trials, and global regulatory landscapes, including FDA, EMA, and other relevant authorities. Exceptional analytical, scientific writing, and interpersonal skills are essential. You will manage and mentor a remote regulatory affairs team, fostering a collaborative and compliant work environment. This position requires meticulous attention to detail, strong project management capabilities, and the ability to navigate complex regulatory challenges effectively. If you are an experienced regulatory affairs professional seeking a challenging and impactful remote leadership role within the pharmaceutical industry, we invite you to apply. Your expertise will be vital in accelerating the availability of life-saving medications to patients worldwide.
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Senior Pharmaceutical Regulatory Affairs Manager
Posted 20 days ago
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Job Description
Our client, a pioneering pharmaceutical company dedicated to developing life-changing therapies, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager to join their esteemed, fully remote team. This critical role will lead regulatory strategy and execution for a portfolio of innovative drug products, ensuring compliance with global health authority requirements. You will be responsible for interpreting complex regulatory guidelines, developing submission strategies, and managing the preparation and filing of regulatory documents for new drug applications (NDAs), supplemental NDAs, and other regulatory submissions. The ideal candidate will possess a deep understanding of pharmaceutical development, manufacturing, and regulatory science, coupled with a proven ability to navigate diverse international regulatory landscapes. As a remote-first leader, you will collaborate extensively with cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing, in a virtual setting. Your expertise in communicating effectively with regulatory agencies and advocating for the company's positions will be paramount. This position requires a proactive, detail-oriented professional with exceptional organizational and project management skills, capable of driving regulatory milestones within tight timelines. You will play a key role in shaping regulatory strategies, advising project teams on regulatory compliance, and ensuring that all activities meet the highest standards of scientific integrity and regulatory scrutiny. This is an unparalleled opportunity to contribute to bringing essential medicines to patients worldwide, leveraging the flexibility of a remote work environment while working for a globally recognized organization. The **location** for this role is considered to be Garissa, Garissa, KE , but the role is entirely remote.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement global regulatory strategies for product development and lifecycle management.
- Manage the preparation, review, and submission of regulatory filings (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Serve as the primary regulatory contact for assigned projects, providing expert guidance and strategic input to cross-functional teams.
- Interpret and apply complex global regulatory requirements, guidelines, and policies.
- Conduct regulatory intelligence activities to monitor changes in the regulatory landscape and assess their impact.
- Lead regulatory agency interactions, including pre-submission meetings and responses to agency queries.
- Ensure compliance with all relevant regulations, including GMP, GCP, and GLP.
- Review and approve labeling, promotional materials, and other regulated product information.
- Develop and maintain strong relationships with key health authorities and external stakeholders.
- Mentor and guide junior regulatory affairs professionals.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline. Advanced degree (M.S., Ph.D., Pharm.D.) is highly preferred.
- 8+ years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and submitting major regulatory filings (e.g., NDAs, MAAs) and achieving approvals.
- In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Strong understanding of drug development processes, from preclinical through commercialization.
- Excellent analytical, strategic thinking, and problem-solving skills.
- Exceptional written and verbal communication and presentation skills, with the ability to clearly articulate complex regulatory issues.
- Proven ability to manage multiple projects simultaneously and work effectively under pressure.
- Strong leadership and team collaboration skills, with experience working in a remote environment.
- Detail-oriented with a high level of accuracy and compliance.
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Senior Pharmaceutical Regulatory Affairs Manager (Remote)
Posted 4 days ago
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Job Description
Our client, a globally recognized pharmaceutical company dedicated to advancing healthcare, is seeking a highly accomplished Senior Pharmaceutical Regulatory Affairs Manager for a fully remote position. This essential role will ensure our client's products meet all required regulatory standards and facilitate smooth market entry and compliance worldwide. You will be responsible for developing and executing regulatory strategies, preparing and submitting regulatory dossiers, and managing interactions with health authorities. Key responsibilities include staying abreast of evolving regulatory landscapes, assessing the impact of new regulations on existing products, and providing expert guidance on compliance matters. The successful candidate will lead the review of labeling, advertising, and promotional materials to ensure regulatory adherence. Experience in negotiating with regulatory agencies and successfully navigating complex approval processes is vital. You will also be involved in lifecycle management of approved products, including post-market surveillance and compliance activities. A minimum of 8 years of progressive experience in pharmaceutical regulatory affairs, with a strong understanding of global regulatory requirements (e.g., FDA, EMA, WHO), is required. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is essential. Excellent analytical, problem-solving, and strategic thinking skills are paramount. Outstanding written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences, are necessary. This remote role, conceptually linked to **Machakos, Machakos, KE**, offers the flexibility to work from anywhere in Kenya and contributes significantly to bringing life-saving medicines to patients globally.
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Senior Financial Risk Manager - Regulatory Compliance
Posted 10 days ago
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Job Description
We are seeking a highly experienced and knowledgeable Senior Financial Risk Manager to join our expanding financial services division. This is a fully remote position, offering the flexibility to manage critical risk functions from anywhere. You will be responsible for developing, implementing, and overseeing the firm's comprehensive risk management framework, with a strong emphasis on regulatory compliance. Your expertise in identifying, assessing, and mitigating financial risks will be crucial in safeguarding the organization and ensuring adherence to evolving regulatory landscapes.
Key Responsibilities:
Key Responsibilities:
- Develop and implement robust risk management policies and procedures across various financial areas, including market risk, credit risk, operational risk, and liquidity risk.
- Conduct comprehensive risk assessments and identify potential vulnerabilities and threats to the organization.
- Design and oversee the execution of risk mitigation strategies and control measures.
- Ensure the firm's compliance with relevant financial regulations (e.g., central bank guidelines, international standards).
- Monitor risk exposures and provide regular reports to senior management and the board of directors.
- Lead internal and external audits related to risk management and compliance.
- Develop and deliver risk management training programs to employees at all levels.
- Stay abreast of changes in the regulatory environment and industry best practices.
- Collaborate with legal, compliance, and business units to integrate risk management into strategic decision-making.
- Manage and mentor a team of risk analysts and specialists.
- Master's degree in Finance, Economics, Risk Management, or a related quantitative field. Professional certifications such as FRM, PRM, or CFA are highly desirable.
- Minimum of 8 years of progressive experience in financial risk management, with a significant focus on regulatory compliance.
- In-depth knowledge of financial markets, instruments, and associated risks.
- Proven expertise in implementing and managing risk management frameworks (e.g., Basel Accords, Solvency II).
- Strong understanding of financial regulations and compliance requirements in the banking and financial services sector.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex risk concepts to diverse audiences.
- Proven leadership and team management experience.
- Ability to work independently and manage multiple priorities in a fast-paced, remote environment.
- Must possess a reliable high-speed internet connection and a dedicated home office setup conducive to managing sensitive financial information and remote collaboration.
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Lead Pharmaceutical Quality Assurance Manager - Regulatory Compliance
Posted 20 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is actively seeking a highly accomplished and visionary Lead Pharmaceutical Quality Assurance Manager to spearhead their quality and compliance initiatives. This is a crucial, fully remote role that will involve overseeing all aspects of quality assurance and regulatory affairs to ensure adherence to international standards and best practices. You will be responsible for developing and implementing comprehensive quality management systems that guarantee the safety, efficacy, and integrity of our client's pharmaceutical products throughout their lifecycle. The ideal candidate will have extensive experience in the pharmaceutical industry, with a proven track record in leading QA teams and navigating complex regulatory landscapes.
Key Responsibilities:
Key Responsibilities:
- Establish, maintain, and continuously improve the company's Quality Management System (QMS) in alignment with cGMP, FDA, EMA, and other relevant global regulatory requirements.
- Lead and mentor a team of Quality Assurance professionals, fostering a culture of quality excellence and continuous improvement.
- Oversee all quality-related activities, including batch record review, release processes, deviation management, CAPA implementation, and change control.
- Develop and manage validation strategies for manufacturing processes, analytical methods, and equipment.
- Conduct internal audits and host regulatory inspections, ensuring preparedness and successful outcomes.
- Collaborate closely with R&D, Manufacturing, and Regulatory Affairs departments to ensure seamless product development and commercialization.
- Monitor and analyze quality metrics, identifying trends and implementing corrective actions to mitigate risks.
- Stay current with evolving regulatory guidelines and best practices in the pharmaceutical industry and implement necessary updates to policies and procedures.
- Manage vendor qualification and audit programs to ensure the quality of supplied materials and services.
- Develop and deliver comprehensive training programs on quality and compliance topics to relevant personnel.
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Senior Pharmaceutical Quality Assurance Manager, Regulatory Compliance
Posted 9 days ago
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Job Description
Our client is seeking a highly skilled and experienced Senior Pharmaceutical Quality Assurance Manager to ensure adherence to stringent regulatory standards in a fully remote capacity. This crucial role will oversee and implement robust quality management systems, guaranteeing compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant global regulations. You will be responsible for developing, implementing, and maintaining comprehensive quality assurance programs, including SOPs, quality risk management, and deviation investigations. Key duties involve conducting internal and external audits, managing regulatory inspections, and ensuring all documentation is accurate, complete, and compliant. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, drug development lifecycle, and regulatory submission requirements. You will lead and mentor a team of quality assurance professionals, fostering a culture of quality excellence and continuous improvement. This role requires strong analytical, problem-solving, and decision-making skills. You will collaborate closely with various departments, including R&D, Manufacturing, and Regulatory Affairs, to ensure consistent quality across all operations. Experience with quality agreements, change control, CAPA (Corrective and Preventive Actions) systems, and complaint handling is essential. We are looking for a candidate with a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field, coupled with a minimum of 8 years of progressive experience in pharmaceutical quality assurance and regulatory affairs. Proven experience in managing quality systems and preparing for regulatory audits (e.g., FDA, EMA) is mandatory. Exceptional communication and interpersonal skills are necessary to effectively lead remote teams and interact with regulatory agencies. This remote position offers the opportunity to make a significant impact on product quality and patient safety from anywhere. You will be a key contributor to ensuring the integrity and reliability of our client's pharmaceutical products, driving compliance and operational excellence. Your ability to interpret complex regulatory guidelines and translate them into practical, implementable procedures will be vital.
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5
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.
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6
Lead Regulatory Compliance Counsel
Posted 19 days ago
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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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7
Senior Aviation Safety Manager - Regulatory Compliance
Posted 18 days ago
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Job Description
Our client, a progressive global aviation services provider, is seeking an exceptional Senior Aviation Safety Manager to lead their remote safety operations. This is a critical, fully remote position responsible for developing, implementing, and managing the company's comprehensive safety management system (SMS) across all its aviation-related activities. The ideal candidate will possess extensive knowledge of international aviation regulations, safety protocols, and risk management principles. You will play a pivotal role in ensuring the highest standards of safety and compliance, fostering a proactive safety culture, and minimizing operational risks. This role demands impeccable analytical abilities, strong leadership, and the capacity to drive safety initiatives effectively within a distributed, remote team. Your expertise will be crucial in maintaining our client's stellar safety record.
Key Responsibilities:
Candidates must hold a Bachelor's degree in Aviation Management, Aerospace Engineering, or a related field. A minimum of 10 years of experience in aviation safety management, with at least 5 years in a senior or managerial role, is required. Proven experience in developing and implementing an effective SMS is essential. Certification from recognized aviation safety programs (e.g., IATA Safety Audit for Ground Operations - ISAGO, Flight Safety Foundation - FSF) is highly desirable. Excellent understanding of ICAO standards and recommended practices (SARPs) is mandatory. Strong analytical, problem-solving, and communication skills, coupled with a demonstrated ability to lead remote teams effectively, are crucial. This role is based in **Mombasa, Mombasa, KE**, but is performed entirely remotely.
Key Responsibilities:
- Develop, implement, and maintain the organization's Safety Management System (SMS) in accordance with ICAO Annex 19 and relevant national regulations.
- Conduct hazard identification, risk assessment, and mitigation planning for all aviation operations.
- Establish and manage safety reporting systems, ensuring timely investigation of incidents and accidents.
- Develop and deliver safety training programs for all levels of personnel.
- Conduct safety audits and inspections to ensure compliance with policies and procedures.
- Monitor safety performance indicators (SPIs) and key risk indicators (KRIs), reporting on trends and recommending corrective actions.
- Foster a positive safety culture through proactive communication, engagement, and leadership.
- Liaise with regulatory authorities and industry bodies on safety matters.
- Manage the safety documentation and records management system.
- Stay abreast of evolving aviation safety regulations, best practices, and emerging safety technologies.
Candidates must hold a Bachelor's degree in Aviation Management, Aerospace Engineering, or a related field. A minimum of 10 years of experience in aviation safety management, with at least 5 years in a senior or managerial role, is required. Proven experience in developing and implementing an effective SMS is essential. Certification from recognized aviation safety programs (e.g., IATA Safety Audit for Ground Operations - ISAGO, Flight Safety Foundation - FSF) is highly desirable. Excellent understanding of ICAO standards and recommended practices (SARPs) is mandatory. Strong analytical, problem-solving, and communication skills, coupled with a demonstrated ability to lead remote teams effectively, are crucial. This role is based in **Mombasa, Mombasa, KE**, but is performed entirely remotely.
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8
Senior Regulatory Compliance Counsel
Posted 5 days ago
Job Viewed
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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