Regulatory Affairs Manager

Nairobi, Nairobi KES600000 - KES1200000 Y OutsideCapital

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Job Description

Our client is a leading player in the fast-paced FMCG sector, dedicated to ensuring a favorable operating environment where they can thrive. With a significant presence across Kenya, Tanzania, and Uganda, they are committed to shaping legislative and regulatory developments to foster sustainable growth and maintain market competitiveness. They operate with a strong focus on responsible business practices and are aligned with global best practices.

Are you a strategic and influential leader passionate about navigating complex regulatory landscapes? Join our client as a Senior Manager, Regulatory Affairs & Policy, and play a pivotal role in shaping their operational environment across East Africa. This is a unique opportunity to drive impactful change, influence policy, and safeguard the company's reputation and bottom line. You will be instrumental in developing and executing strategies that ensure compliance, mitigate risks, and facilitate market access in a dynamic and heavily regulated industry. If you thrive on tackling challenges, building strong stakeholder relationships, and contributing to the strategic direction of a prominent FMCG business, this role is for you.

Responsibilities:

Develop and implement targeted strategies to address specific regulatory challenges and analyze the economic impact of proposed policy changes in Kenya, Tanzania, and Uganda, aligning with global best practices.

Provide a coordinated and integrated organizational approach to anticipate, analyze, and influence legislative and regulatory development and its impact on both business performance and reputation.

Offer guidance and support in the implementation and maintenance of strategies related to regulatory issues, trade, and tax policies to secure competitiveness.

Develop, implement, and monitor anti-counterfeit and anti-parallel business measures and strategies to facilitate market access and mitigate potential risks.

Manage the company's regulatory risk radar, providing early warning and visibility on key regulatory risks to the business.

Ensure early identification of regulatory business risks and align internal stakeholders to address them within the company's business plans.

Manage stakeholder engagements and foster strong relationships with key policy and regulatory stakeholders, representing the company in industry associations and advocating for favorable positions.

Implement best practice methods for issue-based lobbying, including defining company positions, counter-arguments, and stakeholder engagement plans.

Engage with government departments, regulators, industry bodies, and other external stakeholders to advocate on key regulatory issues.

Assist in influencing public policy to support business objectives and provide policy advocacy to regional business units on key issues.

Participate in regulatory forums, ensuring all prioritized regulatory issues are addressed and internal stakeholders are kept informed.

Requirements:

Must-Haves:

Academic Qualifications: Bachelor's Degree in Economics, Law, Public Policy, Political Science, International Relations, or a related discipline.

Professional Qualifications: Member of the Law Society of Kenya.

Experience: At least 6 years of relevant experience, with a minimum of 2 years in a management role within Government, Alcohol, Tobacco, Pharmaceuticals, or another heavily regulated industry, an international institution, or FMCG.

Regulatory Understanding: A good understanding of economic, commercial, and political dynamics in the countries of operation.

Analytical Skills: Ability to undertake research and draft position papers, analyze the impact of regulatory change, and analyze data to make informed decisions.

Policy Knowledge: Knowledge of public policy issues and legislative and political processes.

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Regulatory Affairs Specialist

Nairobi, Nairobi KES600000 - KES1200000 Y Corevix

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Company Description

At COREVIX, we are committed to redefining the aesthetics industry across East Africa by enhancing access to the world's finest beauty and wellness innovations. Through a network of premium medical spas and a portfolio of high-quality consumables, we deliver cutting-edge treatments, advanced technology, and expert-driven solutions. Guided by excellence, innovation, and a customer-centric approach, we strive to inspire confidence, transform lives, and shape the future of aesthetics in the region.

Role Description

This is a full-time on-site role for a Regulatory Affairs Specialist located in Nairobi County, Kenya. The Regulatory Affairs Specialist will be responsible for preparing and submitting regulatory documents, ensuring compliance with regulatory requirements, managing regulatory submissions, and staying up-to-date with regulatory affairs. The Specialist will also liaise with different departments to ensure all regulatory documentation is accurate and meets relevant standards.

Qualifications

  • Experience with Regulatory Documentation and Regulatory Submissions
  • Knowledge of Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
  • Strong attention to detail and excellent organizational skills
  • Ability to work collaboratively and communicate effectively with cross-functional teams
  • Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, or Chemistry
  • At least 2 years of experience in regulatory affairs or a related field
  • Proficiency with regulatory software and data management systems
  • Fluency in English and Swahili would be an advantage
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Senior Corporate Counsel - Compliance & Regulatory Affairs (Remote)

80100 Nairobi, Nairobi KES620000 Annually WhatJobs

Posted 23 days ago

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full-time
Our client, a prominent player in the financial services sector, is seeking a highly accomplished Senior Corporate Counsel with expertise in Compliance and Regulatory Affairs. This is a fully remote position, offering the flexibility to work from anywhere within Kenya. You will be responsible for ensuring the company's adherence to all relevant laws, regulations, and industry standards. This includes developing and implementing robust compliance programs, conducting risk assessments, advising on regulatory changes, and managing regulatory inquiries and audits. The ideal candidate will possess a deep understanding of financial regulations, corporate governance, and risk management principles. You will work closely with senior management and various business units to promote a culture of compliance and ethical conduct throughout the organization. Strong analytical skills, meticulous attention to detail, and excellent communication and interpersonal abilities are essential for success in this role. Join a dedicated legal and compliance team that is committed to upholding the highest standards of integrity, working remotely to support a vital industry with significant operations in Mombasa, Mombasa, KE .

Key Responsibilities:
  • Develop, implement, and maintain comprehensive compliance programs and policies.
  • Monitor regulatory changes and assess their impact on the company's operations.
  • Conduct regular compliance risk assessments and implement mitigation strategies.
  • Advise business units on compliance matters related to financial regulations, data privacy, anti-money laundering (AML), and know-your-customer (KYC) requirements.
  • Manage internal and external audits and respond to regulatory inquiries.
  • Develop and deliver compliance training to employees at all levels.
  • Investigate compliance breaches and recommend corrective actions.
  • Stay current with legal and regulatory developments affecting the financial services industry.
  • Liaise with regulatory authorities and government agencies.
  • Promote a strong culture of ethics and compliance throughout the organization.

Qualifications:
  • Law degree (LLB) from a recognized university and admission to the Kenyan Bar with a valid practicing certificate.
  • Minimum of 8 years of experience in legal and compliance roles, preferably within the financial services industry.
  • In-depth knowledge of Kenyan financial regulations, AML/KYC laws, data protection laws, and corporate governance.
  • Proven experience in developing and implementing compliance programs and conducting risk assessments.
  • Excellent analytical, problem-solving, and strategic thinking skills.
  • Strong written and verbal communication skills, with the ability to explain complex regulatory requirements clearly.
  • Demonstrated ability to manage multiple projects and priorities in a remote environment.
  • High level of integrity, professionalism, and ethical conduct.
  • Experience in advising on international regulatory frameworks is a plus.
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Senior Legal Counsel - Compliance & Regulatory Affairs

80100 Nairobi, Nairobi KES1100000 Annually WhatJobs

Posted 23 days ago

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full-time
Our client is seeking an experienced and highly motivated Senior Legal Counsel to lead their Compliance and Regulatory Affairs function. This is a fully remote position that demands a deep understanding of Kenyan and international regulatory landscapes, particularly within the financial services or technology sectors. You will be responsible for ensuring the company's adherence to all applicable laws and regulations, managing compliance programs, and advising on regulatory risks.

Key Responsibilities:
  • Develop, implement, and manage comprehensive compliance programs and policies.
  • Monitor changes in relevant laws and regulations and assess their impact on the business.
  • Advise senior management and business units on regulatory requirements and compliance strategies.
  • Conduct internal investigations and audits to ensure adherence to policies and regulations.
  • Manage relationships with regulatory bodies and external auditors.
  • Oversee the company's anti-money laundering (AML) and know your customer (KYC) initiatives.
  • Provide legal guidance on data privacy regulations (e.g., GDPR, Kenyan Data Protection Act).
  • Develop and deliver compliance training programs for employees.
  • Review and advise on marketing materials and product offerings for regulatory compliance.
  • Manage regulatory filings and reporting obligations.
  • Represent the company in interactions with regulatory agencies.
The ideal candidate will possess a law degree (LLB) and a professional qualification such as a Post Graduate Diploma in Law, with admission to the bar as an Advocate of the High Court of Kenya. A minimum of 8 years of relevant experience in compliance, regulatory affairs, or corporate law, preferably within a regulated industry, is required. Strong analytical skills, excellent communication and interpersonal abilities, and the capacity to work independently in a remote setting are essential. Experience with risk management frameworks and a proactive approach to compliance are highly valued. This is a critical role for ensuring the company's integrity and lawful operation.
Location: This position is 100% remote. While the legal team has a presence in Mombasa, Mombasa, KE , the role offers complete location flexibility for the right candidate.
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Senior Remote Pharmaceutical Regulatory Affairs Specialist

80100 Nairobi, Nairobi KES150000 Annually WhatJobs

Posted 6 days ago

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full-time
Our client is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to lead and manage regulatory submissions and compliance efforts. This fully remote position allows you to contribute significantly to bringing life-saving medications to market from the convenience of your home office. You will be responsible for interpreting and applying global regulatory guidelines, preparing comprehensive regulatory dossiers, and ensuring timely submissions to health authorities worldwide. Key duties include developing regulatory strategies, liaising with regulatory agencies, conducting regulatory intelligence activities, and advising internal teams on regulatory requirements and potential challenges. The ideal candidate will possess a strong background in pharmaceutical sciences or a related field, with extensive experience in regulatory affairs for both pre-market approval and post-market activities. A deep understanding of regulatory submission processes (e.g., CTD, IND, NDA) and familiarity with international regulatory landscapes (e.g., FDA, EMA) are essential. Excellent written and verbal communication skills are critical for effectively preparing submission documents and interacting with regulatory bodies. You must demonstrate strong analytical and problem-solving abilities, meticulous attention to detail, and the capacity to manage complex projects under tight deadlines. This role requires a proactive and strategic thinker with the ability to anticipate regulatory changes and provide sound advice. Proficiency in regulatory information management systems is a plus. Join our client’s esteemed regulatory team and play a vital role in ensuring the successful and compliant market access of innovative pharmaceutical products. Your expertise will be invaluable in navigating the complex regulatory environment.
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Remote Senior Pharmaceutical Regulatory Affairs Specialist

80100 Nairobi, Nairobi KES150000 Annually WhatJobs

Posted 13 days ago

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full-time
Our client is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This critical role involves navigating the complex landscape of pharmaceutical regulations to ensure our products meet all necessary compliance requirements for market entry and distribution globally. The ideal candidate will possess a comprehensive understanding of drug development, clinical trials, and the regulatory submission processes across key international markets (e.g., FDA, EMA, WHO). You will be responsible for preparing, reviewing, and submitting regulatory dossiers, responding to regulatory authority inquiries, and advising R&D and commercial teams on regulatory strategies. This position requires meticulous attention to detail, exceptional analytical skills, and the ability to interpret and apply intricate regulatory guidelines. Collaboration with internal stakeholders, including legal, R&D, and marketing departments, will be essential to align regulatory strategies with business objectives. The successful candidate will stay abreast of evolving regulatory landscapes and proactively identify potential challenges and opportunities. This is a significant opportunity for a seasoned professional to lead regulatory efforts in a dynamic, remote-first pharmaceutical company. We are committed to fostering a work environment that values expertise, collaboration, and innovation. Responsibilities:
  • Develop and implement global regulatory strategies for pharmaceutical products.
  • Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, CTAs).
  • Liaise with regulatory health authorities worldwide.
  • Ensure compliance with all applicable pharmaceutical regulations and guidelines.
  • Advise project teams on regulatory requirements throughout the product lifecycle.
  • Monitor and interpret changes in global pharmaceutical regulations.
  • Conduct regulatory intelligence gathering and analysis.
  • Manage post-approval regulatory activities, including lifecycle management.
  • Review and approve labeling and promotional materials for regulatory compliance.
  • Contribute to the development of SOPs and internal regulatory policies.

Qualifications:
  • Master's degree or Pharm.D. in Pharmacy, Life Sciences, or a related field.
  • Extensive experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of global pharmaceutical regulatory requirements and submission processes.
  • Proven track record of successful regulatory submissions.
  • Strong analytical, strategic thinking, and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work independently, manage projects effectively, and meet strict deadlines in a remote setting.
  • Experience with regulatory information management systems is a plus.
  • Familiarity with different therapeutic areas is advantageous.
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Senior Pharmaceutical Regulatory Affairs Specialist - Remote

80100 Nairobi, Nairobi KES190000 Annually WhatJobs

Posted 23 days ago

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full-time
Our client, a highly respected pharmaceutical company committed to advancing global health, is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This pivotal role involves ensuring that all company products comply with national and international regulatory requirements throughout their lifecycle, from development to post-market surveillance. You will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities, responding to regulatory inquiries, and staying abreast of evolving regulatory landscapes. The ideal candidate will possess in-depth knowledge of pharmaceutical regulations, guidelines, and submission processes. Your responsibilities will include developing regulatory strategies, advising R&D teams on regulatory compliance, and managing the regulatory aspects of product registrations and approvals. Strong analytical skills, meticulous attention to detail, and excellent written and verbal communication are essential for success in this position. You will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Commercial departments, to facilitate timely market access for innovative therapies. This fully remote role requires a self-motivated and organized professional capable of managing multiple projects and deadlines independently. You will play a critical role in bringing life-saving and life-enhancing medications to patients worldwide, contributing significantly to the company's mission while enjoying the flexibility of a remote work environment. The ability to interpret complex regulatory requirements and translate them into practical, actionable guidance for the organization is paramount.
Responsibilities:
  • Develop and implement global regulatory strategies for product development and lifecycle management.
  • Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
  • Serve as the primary regulatory contact for assigned projects and products.
  • Respond to questions and requests from regulatory agencies.
  • Monitor and interpret evolving regulatory guidelines and legislation impacting the pharmaceutical industry.
  • Provide regulatory guidance and support to R&D, Quality, and Commercial teams.
  • Assess the regulatory impact of proposed changes to product manufacturing, labeling, and marketing.
  • Ensure compliance with all applicable GMP, GCP, and GLP regulations.
  • Manage post-approval regulatory activities, including supplements and variations.
  • Maintain regulatory documentation and databases.
  • Contribute to the continuous improvement of regulatory processes and systems.
Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline; Master's degree or Pharm.D. is a plus.
  • Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
  • Comprehensive knowledge of global regulatory submission requirements and guidelines (e.g., FDA, EMA, ICH).
  • Proven experience in preparing and submitting major regulatory filings.
  • Excellent understanding of drug development processes and pharmaceutical manufacturing.
  • Strong analytical, problem-solving, and strategic thinking skills.
  • Exceptional written and verbal communication skills, with a high degree of accuracy.
  • Ability to work independently and manage multiple priorities in a remote setting.
  • Detail-oriented with strong organizational skills.
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About the latest Lead ai ethics and governance specialist Jobs in Nairobi !

Lead AI Ethics and Governance Specialist

80100 Nairobi, Nairobi KES250000 Annually WhatJobs remove_red_eye View All

Posted 9 days ago

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full-time
Our client is at the forefront of AI innovation and is seeking an accomplished Lead AI Ethics and Governance Specialist to guide the responsible development and deployment of artificial intelligence technologies. This fully remote position is crucial for ensuring our AI systems are developed and utilized in a manner that is fair, transparent, and accountable. You will be responsible for establishing and enforcing ethical guidelines, developing comprehensive governance frameworks, and conducting rigorous impact assessments for new AI initiatives. Your expertise will shape policies related to data privacy, bias mitigation, and algorithmic transparency. This role involves close collaboration with R&D teams, legal counsel, and product managers to embed ethical considerations into the entire AI lifecycle. You will also lead the creation of training programs for internal teams on AI ethics and best practices, fostering a culture of responsible innovation. The ideal candidate will have a strong background in AI principles, ethics, philosophy, law, or a related field, coupled with practical experience in AI governance. Excellent analytical and problem-solving skills are essential, as is the ability to translate complex ethical concepts into actionable strategies. You must be adept at navigating ambiguous situations and influencing stakeholders at all levels. This position requires exceptional communication skills, both written and verbal, to articulate complex ideas clearly and persuasively to diverse audiences. A demonstrated passion for ensuring AI benefits humanity is paramount. Responsibilities include: researching emerging ethical challenges in AI, developing and implementing AI ethics review processes, managing AI risk assessments, and contributing to public discourse on AI governance. This is an opportunity to shape the ethical landscape of AI on a global scale from a remote work setting. We seek individuals who are proactive, self-motivated, and possess a strong sense of integrity.
Location: This role is based remotely but is aligned with our core operations in **Mombasa, Mombasa, KE**.
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Lead AI Ethics & Governance Specialist

80100 Nairobi, Nairobi KES300000 Annually WhatJobs

Posted 8 days ago

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full-time
Our client is seeking an experienced Lead AI Ethics & Governance Specialist to join their pioneering AI & Emerging Technologies division. This fully remote role is critical in establishing and overseeing the ethical frameworks and governance policies for our advanced AI systems. You will be responsible for ensuring our AI technologies are developed and deployed responsibly, transparently, and equitably. This is a high-impact position for a professional passionate about the societal implications of artificial intelligence.

Responsibilities:
  • Develop, implement, and maintain robust AI ethics policies and guidelines.
  • Conduct ethical risk assessments for new AI projects and applications.
  • Advise development teams on best practices for responsible AI development.
  • Monitor and audit AI systems for fairness, bias, transparency, and accountability.
  • Engage with stakeholders, including legal, compliance, and external experts, on AI ethics issues.
  • Develop training programs and resources on AI ethics for internal teams.
  • Stay abreast of evolving regulations, standards, and best practices in AI ethics and governance globally.
  • Contribute to public discourse and thought leadership on responsible AI.
  • Manage the ethical review process for AI-related initiatives.
  • Foster a culture of ethical awareness and responsibility across the organization.

Qualifications:
  • Master's degree or Ph.D. in Computer Science, Philosophy, Law, Public Policy, or a related field with a focus on AI ethics.
  • Minimum of 6 years of experience in AI ethics, responsible AI, AI governance, or a closely related field.
  • Deep understanding of AI technologies, machine learning principles, and their ethical implications.
  • Familiarity with relevant legal frameworks, regulatory landscapes, and industry standards for AI.
  • Proven ability to develop and implement complex policy frameworks.
  • Excellent analytical, critical thinking, and problem-solving skills.
  • Exceptional written and verbal communication and presentation skills.
  • Ability to engage effectively with diverse technical and non-technical audiences.
  • Demonstrated ability to work independently and lead initiatives in a remote setting.
  • Strong project management and organizational skills.
This is a fully remote opportunity, allowing you to contribute your expertise to the forefront of AI innovation from anywhere. You will play a crucial role in shaping the future of AI by ensuring its ethical and responsible development. The ideal candidate is a thought leader, a proactive problem-solver, and committed to navigating the complex ethical challenges of advanced technology in a remote-first environment.
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Lead AI Ethics & Governance Specialist (Remote)

80204 Nairobi, Nairobi KES120000 Annually WhatJobs

Posted 13 days ago

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full-time
Our client, a pioneering firm at the forefront of artificial intelligence research and development, is seeking a visionary Lead AI Ethics & Governance Specialist to join their entirely remote, world-class team. This critical role will be responsible for establishing and overseeing the ethical frameworks, governance policies, and responsible AI practices that guide the development and deployment of advanced AI systems. The ideal candidate will possess a profound understanding of AI technologies, ethical considerations, regulatory landscapes, and societal impacts. You will collaborate closely with AI researchers, engineers, legal counsel, and policy experts to ensure our client's AI innovations are developed and utilized in a manner that is fair, transparent, accountable, and beneficial to humanity. Key responsibilities include developing robust AI governance models, conducting ethical risk assessments, creating training programs on responsible AI, and advising leadership on emerging ethical challenges. A strong ability to articulate complex technical and ethical concepts to diverse audiences, coupled with exceptional research and analytical skills, is essential. This is a unique opportunity to shape the future of AI and influence the trajectory of responsible technological advancement from a remote position. Your expertise will be crucial in building trust and ensuring public confidence in AI technologies. This role is conceptually anchored in Malindi, Kilifi, KE , but is a fully remote position, allowing us to draw talent from across the globe. You will be at the vanguard of ensuring ethical considerations are deeply embedded in every stage of the AI lifecycle, from conception to implementation, fostering a culture of responsible innovation. The impact of this role extends to shaping industry standards and contributing to a future where AI serves humanity equitably and safely.
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