What Regulatory Affairs Jobs are in Kenya?

• Develop, implement, and manage the company's compliance program.
• Monitor changes in relevant laws and regulations and assess their impact on the business.
• Conduct internal investigations and respond to regulatory inquiries.
• Provide legal advice on compliance-related matters, including data privacy, anti-corruption, and sanctions.
• Draft and review compliance policies, procedures, and training materials.
• Liaise with regulatory bodies and external counsel on compliance issues.
• Advise on risk management strategies related to regulatory compliance.
• Assist in the preparation of regulatory filings and disclosures.
• Stay abreast of industry best practices in compliance and governance.
• Promote a strong ethical culture throughout the organization.

• Law degree (LLB or equivalent) and a valid Kenyan practicing certificate.
• Minimum of 5 years of experience in compliance, regulatory affairs, or a related legal field.
• In-depth knowledge of Kenyan and international laws and regulations relevant to the company's industry.
• Proven experience in developing and implementing compliance programs.
• Strong analytical and research skills.
• Excellent written and verbal communication abilities.
• Ability to work autonomously and manage deadlines effectively in a remote setting.
• High degree of professional ethics and integrity.
• Experience with cross-border regulatory issues is a plus.
• Proficiency in legal research tools and case management software.

• Competitive annual salary.
• Remote work flexibility with a home office setup allowance.
• Comprehensive health coverage.
• Opportunities for professional growth and specialized training.
• Company-provided laptop and necessary software.
• Paid leave and public holidays.
• Contribution to a retirement savings plan.
• Access to a global network of legal professionals.
• Supportive virtual team environment.
• Regular performance reviews with clear development paths.

• Provide expert legal advice and strategic guidance on regulatory matters affecting the telecommunications industry.
• Monitor, interpret, and advise on changes in relevant laws, regulations, and policies.
• Prepare and submit regulatory filings, applications, and responses to regulatory authorities.
• Represent the company in interactions with regulators, government agencies, and industry bodies.
• Develop and implement regulatory compliance programs and strategies.
• Conduct legal research and analysis on complex regulatory issues.
• Advise on licensing requirements, spectrum management, and other regulatory compliance obligations.
• Support the business units in navigating regulatory approvals and challenges.
• Manage external regulatory counsel and advise on regulatory advocacy efforts.
• Ensure the company's adherence to data privacy and consumer protection regulations in the telecommunications sector.

• A Bachelor of Laws (LLB) degree from a recognized university and a Post Graduate Diploma in Legal Practice.
• Admitted to the bar as an Advocate of the High Court of Kenya with a current practicing certificate.
• A minimum of 7 years of progressive experience in regulatory law, with a significant focus on the telecommunications sector.
• In-depth knowledge of telecommunications law, regulatory frameworks, and policy issues in Kenya and ideally across the region.
• Proven experience in regulatory compliance, advocacy, and engagement with regulatory bodies.
• Excellent analytical, strategic thinking, and problem-solving skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory positions effectively.
• Demonstrated ability to work independently and manage multiple complex projects in a remote setting.
• Strong understanding of data privacy and consumer protection laws relevant to the industry.
• Ability to collaborate effectively with remote teams and cross-functional stakeholders.

• Provide expert legal and strategic advice on all aspects of energy sector regulation in Kenya and relevant international jurisdictions.
• Monitor, interpret, and advise on changes in energy laws, regulations, and policies.
• Develop and implement compliance programs to ensure adherence to regulatory requirements.
• Represent the company in interactions with regulatory agencies, including license applications, reporting, and investigations.
• Draft, review, and negotiate agreements related to energy projects, including power purchase agreements and grid connection agreements.
• Conduct regulatory due diligence for mergers, acquisitions, and new project developments.
• Manage regulatory litigation and administrative proceedings.
• Develop and deliver training on regulatory compliance matters to internal stakeholders.
• Contribute to the development of company positions on key regulatory and policy issues.

• A Bachelor of Laws (LLB) degree from a reputable university.
• Admission to the bar in Kenya with a valid practicing certificate.
• A minimum of 8-10 years of specialized experience in energy law and regulatory affairs.
• Proven experience in advising on power generation, transmission, distribution, and renewable energy regulations.
• Strong understanding of the Kenyan energy sector regulatory framework and key stakeholders.
• Experience in negotiating complex energy contracts is essential.
• Excellent analytical, strategic thinking, and problem-solving skills.
• Superior written and verbal communication and advocacy skills.
• Demonstrated ability to work independently and manage complex projects in a remote environment.
• Proactive approach to regulatory risk management.

• Highly competitive annual salary of KSh.
• Fully remote work arrangement, offering exceptional flexibility.
• Opportunity to influence regulatory policy and shape the future of the energy sector.
• Work on significant energy projects and complex regulatory challenges.
• Comprehensive health, life, and disability insurance.
• Professional development and continuous learning opportunities.
• Contribution to a mission-driven organization focused on sustainable energy solutions from **Garissa, Garissa, KE**.
• Generous vacation and paid time off.

• Author, edit, and review a variety of regulatory documents, including Investigational New Drug (IND) applications, Clinical Study Reports (CSRs), New Drug Applications (NDAs), and responses to regulatory agency questions.
• Ensure all submitted documents are scientifically accurate, complete, consistent, and compliant with applicable regulatory guidelines and company standards.
• Collaborate effectively with cross-functional teams (e.g., clinical, medical, biostatistics, regulatory strategy) to gather necessary information and ensure the accuracy and integrity of documentation.
• Manage multiple projects simultaneously, ensuring adherence to strict timelines and quality standards.
• Stay updated on evolving regulatory requirements, guidelines, and industry best practices for medical and regulatory writing.
• Contribute to the development and refinement of document templates and writing standards.
• Provide guidance and mentorship to junior medical writers as needed.
• Review and edit documents authored by other team members or external contractors.

• Bachelor's degree in a scientific or health-related field (e.g., Life Sciences, Pharmacy, Nursing); advanced degree (Master's or Ph.D.) is preferred.
• Minimum of 5-7 years of experience as a Medical Writer, with a significant portion focused on regulatory submissions in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in authoring key regulatory documents (e.g., INDs, NDAs, CSRs).
• Thorough understanding of ICH guidelines and regulatory submission requirements in major markets (e.g., US, EU).
• Exceptional written and verbal communication skills, with a meticulous attention to detail.
• Proven ability to interpret complex scientific and clinical data and present it clearly and concisely.
• Strong organizational and project management skills, with the ability to manage multiple priorities in a remote setting.
• Proficiency in Microsoft Office Suite and familiarity with regulatory document management systems is a plus.
• Ability to work independently and collaboratively within a remote team environment.

JOB TITLE: REGULATORY AFFAIRS ASSISTANT

About This Job:

Q-Sourcing Limited trading as Q-Sourcing Servtec is a manpower management solutions firm operating in the East African Region in the countries of Uganda, Kenya, Tanzania, Rwanda, and South Sudan.

On behalf of our client, we are looking for a competent, skilled, and experienced Regulatory Affairs Assistant to work in Kenya.

Job Purpose

To ensure business compliance to regulations and standards according to the Good Warehousing Practice as outlined by the Pharmacy and Poisons Board (PPB) and adherence to Standard Operating Procedures that govern compliance to ISO 9001:2015.

Key Responsibilities

1. Regulatory Compliance

·    Apply for import permits according to the Pharmacy and Poisons Board (PPB) rules.

·    Ensure all documentation required for official records is filed and easily retrievable.

2. Audits & Non-Conformance Management

·    Ensure that non-conformances are initiated, reviewed, and evaluated.

·    Ensure non-conformances are closed within 30 days of initiation.

·    Prepare non-conformance trends and reports.

3. Environmental Management

·    Participate in the implementation of departmental and site Environmental Management System (EMS) objectives.

·    Ensure EMS objectives are monitored and measured.

4. Documentation & Reporting

·    Handle all documentation needed for official records in line with established SOPs and working instructions.

·    Prepare weekly reports on regulatory activities.

·    Perform any other duties as assigned by Management from time to time.

Education

·    Diploma in Pharmacy, Clearing and Forwarding, Information Technology, or a related field.

Experience

·    Experience in document management is required.

·    Prior exposure to regulatory affairs or compliance roles is an added advantage.

Technical Skills

·    Computer literacy, including proficiency in Microsoft Office applications.

·    Knowledge of document management systems.

·    Understanding of regulatory requirements (PPB, ISO 9001:2015) is an added advantage.

Core Competencies

·    Strong attention to detail and organizational skills.

·    Ability to work under pressure and meet deadlines.

·    Excellent communication and interpersonal skills.

·    Integrity and ability to handle confidential information.

·    Team player with a proactive attitude.

Interested and qualified applicants should submit their applications through the link below.

Note: Only shortlisted applicants will be contacted.

Q-SOURCING SERVTEC IS AN EQUAL OPPORTUNITY EMPLOYER. ANY SOLICITATION WILL LEAD TO DISQUALIFICATION.

• Develop, implement, and maintain comprehensive compliance policies and procedures.
• Monitor changes in relevant laws and regulations (e.g., CBK regulations, AML, KYC) and assess their impact on the organization.
• Conduct regular compliance risk assessments and internal audits.
• Investigate potential compliance breaches and recommend corrective actions.
• Develop and deliver compliance training programs for employees.
• Prepare and file regulatory reports with relevant authorities.
• Serve as the primary point of contact for regulatory bodies and external auditors on compliance matters.
• Advise senior management on compliance-related issues and emerging risks.
• Ensure the company maintains a strong anti-money laundering (AML) and know your customer (KYC) framework.

• Bachelor's degree in Law, Finance, Business Administration, or a related field. A Master's degree or relevant professional certification (e.g., CAMS, CRCM) is highly desirable.
• Minimum of 6 years of experience in compliance, risk management, or legal roles within the **Banking & Finance** industry.
• In-depth knowledge of Kenyan financial regulations, AML/CFT laws, and other relevant compliance frameworks.
• Proven experience in developing and implementing compliance programs.
• Strong analytical and problem-solving skills, with excellent attention to detail.
• Exceptional communication and presentation skills, both written and verbal.
• Ability to work effectively with cross-functional teams and manage complex projects.
• Experience in the **Ongata Rongai** or broader Kajiado financial market is a plus.
• Proficiency in compliance management software and tools.

• Competitive salary and performance-based incentives.
• Comprehensive health and wellness benefits package.
• Retirement savings plan.
• Paid time off and public holidays.
• Opportunities for professional development and continuous learning.
• Hybrid work model offering flexibility and work-life balance.
• A challenging and rewarding role within a reputable financial institution in **Ongata Rongai**.

• Monitor, interpret, and implement new and existing insurance regulations and legislation.
• Develop, update, and maintain the company's compliance policies and procedures manual.
• Conduct regular internal audits and risk assessments to ensure adherence to regulatory requirements.
• Investigate potential compliance breaches and recommend corrective actions.
• Provide compliance training and awareness programs to employees across various departments.
• Act as the primary point of contact for regulatory bodies and respond to inquiries.
• Prepare and submit regulatory reports to relevant authorities.
• Advise management and business units on compliance best practices and potential risks.
• Manage the company's compliance management system.
• Stay abreast of industry trends and changes affecting insurance compliance.

• Bachelor's degree in Law, Business Administration, Finance, or a related field.
• Minimum of 4 years of experience in compliance, legal, or audit roles within the insurance industry.
• In-depth knowledge of Kenyan insurance laws and regulations (e.g., Insurance Act).
• Strong analytical, research, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to draft clear policies and reports.
• High ethical standards and integrity.
• Experience in conducting internal audits and risk assessments.
• Proficiency in Microsoft Office Suite.
• Ability to work independently and collaboratively with different teams in **Kakamega, KE**.
• Professional certifications in compliance (e.g., CCEP, ACAMS) are a significant advantage.

• Competitive annual salary package up to KSh, commensurate with experience.
• Comprehensive health insurance and wellness benefits.
• Opportunities for professional development and advanced compliance training.
• Support for obtaining relevant professional certifications.
• A stable and reputable company environment.
• Annual leave and paid public holidays.
• Company pension scheme.
• Contribution to a positive and ethical work culture.

• Prepare, review, and compile high-quality regulatory submission documentation (e.g., INDs, NDAs, MAAs, supplements) in accordance with relevant agency guidelines (FDA, EMA, etc.).
• Manage and maintain regulatory filings throughout the product lifecycle, including annual reports, amendments, and variations.
• Interface with regulatory agencies on behalf of the company, responding to queries and facilitating communication.
• Ensure compliance with all applicable local, regional, and international regulations and guidelines related to pharmaceutical product development and marketing.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to provide regulatory guidance and ensure project timelines are met.
• Monitor regulatory intelligence and update internal stakeholders on changes in the regulatory landscape that may impact the company's products or strategy.
• Support regulatory strategy development for new product registrations and lifecycle management activities.
• Review promotional and advertising materials for regulatory compliance.
• Maintain regulatory databases and filing systems.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. Advanced degree (e.g., Master's, Pharm.D.) is a plus.
• Minimum of 4 years of experience in regulatory affairs within the **pharmaceutical** or biotechnology industry.
• In-depth knowledge of regulatory requirements and guidelines in major markets (e.g., US, EU).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Strong understanding of drug development processes and pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with a talent for clear and concise documentation.
• Ability to manage multiple projects simultaneously and meet strict deadlines in a remote setting.
• Proficiency in using regulatory information management systems (RIMS) and common office software.
• Self-motivated with the ability to work independently and collaboratively in a virtual team environment.