1,173 Pharmaceutical Compliance jobs in Kenya

• Develop and implement global regulatory strategies for pharmaceutical products.
• Prepare and manage the submission of regulatory dossiers (e.g., INDs, NDAs, MAAs) in various regions.
• Lead communication and interactions with global health authorities (e.g., FDA, EMA, MHRA).
• Oversee post-approval regulatory activities, including variations, renewals, and compliance reporting.
• Provide regulatory guidance and support to R&D, clinical development, manufacturing, and commercial teams.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
• Conduct regulatory intelligence activities and assess the impact of new regulations.
• Manage and mentor junior regulatory affairs specialists.
• Participate in regulatory inspections and audits.
• Contribute to the development and improvement of regulatory processes and systems.

• Advanced degree (e.g., Master's, PhD) in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets.
• In-depth knowledge of global pharmaceutical regulations, guidelines (ICH), and compliance requirements.
• Experience with Common Technical Document (CTD) format.
• Strong leadership, project management, and organizational skills.
• Excellent written and verbal communication and negotiation skills.
• Ability to analyze complex scientific and regulatory information.
• Experience working in a fully remote or geographically dispersed team is highly desirable.
• Familiarity with pharmacovigilance and quality assurance principles.

• Develop and execute regulatory strategies for pharmaceutical product registration and lifecycle management.
• Prepare, review, and submit high-quality regulatory submissions (e.g., NDAs, MAAs) to global health authorities.
• Manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Ensure compliance with local and international pharmaceutical regulations, guidelines, and standards.
• Liaise with regulatory agencies, build strong relationships, and respond to agency inquiries.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Manufacturing, and Marketing.
• Review and approve product labeling, marketing materials, and promotional claims for regulatory compliance.
• Monitor and assess emerging regulatory trends and advise the business on potential impacts and opportunities.

• A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or specialized regulatory affairs certification is a plus.
• Minimum of 6-8 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of Kenyan and relevant international pharmaceutical regulatory requirements (e.g., FDA, EMA).
• Proven experience in preparing and submitting successful regulatory dossiers.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Demonstrated ability to work independently and collaboratively in a remote team environment.
• Familiarity with pharmacovigilance and quality assurance principles.

• Developing, implementing, and overseeing pharmaceutical quality assurance programs and policies.
• Conducting internal and external audits of manufacturing facilities, laboratories, and clinical trial sites to ensure compliance with regulatory standards (e.g., FDA, EMA, WHO).
• Reviewing and approving batch records, validation protocols, and other critical quality documentation.
• Investigating deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Ensuring that all pharmaceutical products meet predefined quality specifications and regulatory requirements before release.
• Collaborating closely with R&D, manufacturing, regulatory affairs, and clinical teams to ensure quality is integrated throughout the product lifecycle.
• Developing and delivering quality assurance training programs for relevant personnel.
• Managing and maintaining the company's Quality Management System (QMS), including document control, change control, and risk management processes.
• Staying updated on current pharmaceutical regulations, industry trends, and best practices in quality assurance.
• Preparing for and hosting regulatory inspections and customer audits.

• A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Ph.D. is a plus.
• A minimum of 7-10 years of progressive experience in pharmaceutical quality assurance and/or quality control.
• In-depth knowledge of GMP, GCP, ICH guidelines, and other relevant global regulatory requirements.
• Proven experience in conducting successful regulatory audits and hosting inspections.
• Strong analytical skills with the ability to interpret complex data and resolve quality issues effectively.
• Excellent project management and organizational skills, with the ability to manage multiple tasks and projects concurrently in a remote setting.
• Outstanding written and verbal communication skills, with the ability to articulate complex quality and regulatory issues clearly.
• Proficiency in quality management software and tools.
• A proactive approach to problem-solving and a commitment to maintaining the highest quality standards.

HFC Limited, the banking and property finance subsidiary of HF Group, has an exciting opportunity in our Risk & Compliance Department. We are seeking a talented, dynamic, self-driven, and results-oriented individual who is committed to performance, excellence, and participating in our growth strategy.

To promote AML/CFT compliance objectives within the Bank and contribute to the development of a strong AML/CFT compliance culture throughout the organization.

Deadline:

Category: Risk and Compliance

Subsidiary: HFC

Principle Accountabilities

• Conduct and regularly update the Bank's AML/CFT/CPF risk assessment.
• Champion initiatives to further strengthen the culture of AML/CFT/CPF Compliance across all lines of business by ensuring visibility of the AML/CFT/CPF agenda.
• Act as a point of reference to the business on AML/CFT/CPF-related issues.
• Work closely with the Business to identify suspicious transactions for ML/TF & PF with emphasis on higher risk customers and transactions.
• Receive, review and investigate Suspicious Transaction Reports and forward to MLRO for review.
• Perform sanctions, PEP and adverse media screening program.
• Researching and advising the business on emerging trends and regulations touching on AML/CFT/CPF.
• Escalate and report AML/CFT/CPF compliance issues to MLRO as well as the plans for resolution.
• Review the company AML/CFT/CPF policy on regular basis to ensure completeness and consistency with emerging AML/CFT/CPF compliance requirements.
• Monitoring of transactions for suspicious activities and closure/escalation of alerts.
• Ensure screening of customers is conducted at onboarding and periodically against sanction lists, internal caution and Black lists, and PEP database.
• With emphasis on high risk customer, conduct regular reviews of newly opened accounts to ensure compliance with the requirements.
• Conduct AML/CFT/CPF risk checks on new products and services prior to introduction.
• Preparation and filing of compliance reports.
• Prompt response to regulatory requests i.e. FRC, CBK, EACC, KRA, KBA etc
• Attend AML/CFT/CPF compliance related meetings with external stake holders, as the AML/CFT/CPF compliance representative.
• Assist in implementing a bank-wide AML/CFT/CPF program through risk awareness training program for all staff especially on identification and reporting of suspicious transactions
• Maintain detailed knowledge of current AML/CFT/CPF regulations and keep track of developments within the AML/CFT/CPF scope, sanctions, terrorist financing issues, including policies, procedures, industry best practice, criminal typologies and developing trends.
• Maintain strong working relationships with internal stakeholders to ensure that compliance issues are regularly discussed and addressed.
• Monitor and track closure of management actions from the compliance reviews, regulator' and External auditor' reports.
• Prepare monthly and quarterly reports on the state of AML/CFT/CPF program to the Risk Management Committee and the Board.
• Report control weaknesses or lapses to the senior compliance manager/MLRO in a timely manner, recommend mitigation controls or process and policy changes and follow up implementation of agreed actions.
• Execution of instructions and any other duties from the Senior Manager Compliance, as assigned from time to time.

Key Competencies and Skills

General Competencies

• Communication skills
• I.T. Skills (Ms office)
• Creativity
• Team player
• High levels of professionalism and professional development.
• Honest with impeccable integrity (high ethical standards)

Technical Competencies

• Deep knowledge of the regulatory environment with regard to AML/CFT regulations.
• Ability to understand and document workflows and business processes
• Strong analytical and monitoring skills
• Good report writing and presentation skills
• Working knowledge of Go-AML System
• Working knowledge of AML software applications

Minimum Qualifications, Knowledge And Experience
Academic & Professional

• Bachelor's Degree in Commerce, Finance, Banking, Law, Risk Management or a related field
• Certification in Anti-Money Laundering.

Experience

• 3 years' experience in the Banking industry and at least 1 year in AMLCFT/CPF compliance role within enterprise risk management framework.

• Develop, implement, and maintain a comprehensive compliance program across the organization.
• Monitor and interpret relevant laws, regulations, and industry standards to ensure organizational adherence.
• Conduct regular compliance risk assessments and identify potential areas of non-compliance.
• Develop and deliver compliance training programs for employees at all levels.
• Investigate potential compliance violations and recommend appropriate corrective actions.
• Prepare and submit regulatory reports as required.
• Maintain accurate and up-to-date records of compliance activities.
• Advise management on compliance-related issues and best practices.
• Stay informed about changes in the regulatory environment and update policies and procedures accordingly.
• Liaise with regulatory agencies and external auditors as needed.
• Promote a culture of compliance and ethical behavior throughout the organization.
• Ensure data privacy and security compliance in accordance with relevant legislation.

• Bachelor's degree in Law, Business Administration, or a related field. Relevant professional certifications (e.g., CCEP) are a strong asset.
• Minimum of 5 years of experience in a compliance, legal, or risk management role, preferably within a regulated industry.
• Solid understanding of relevant Kenyan laws and regulations, as well as international compliance standards.
• Experience in developing and implementing compliance policies and procedures.
• Excellent analytical, problem-solving, and investigative skills.
• Strong written and verbal communication skills, with the ability to explain complex regulations clearly.
• Proficiency in Microsoft Office Suite and compliance management software.
• Ability to work independently and manage multiple priorities in a remote setting.
• High level of integrity, discretion, and attention to detail.

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global GMP guidelines (e.g., FDA, EMA, PIC/S).
• Oversee and manage all aspects of pharmaceutical quality assurance, including batch record review, deviation management, CAPA (Corrective and Preventive Actions), change control, and OOS (Out-of-Specification) investigations.
• Lead internal and external audits, including regulatory inspections, and ensure effective follow-up on audit findings.
• Develop and deliver comprehensive training programs to ensure staff are well-versed in GMP principles and quality procedures.
• Monitor and evaluate the performance of quality control processes, identifying areas for improvement and implementing corrective measures.
• Review and approve validation protocols and reports for equipment, processes, and analytical methods.
• Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure quality is embedded throughout the product lifecycle.
• Stay current with evolving pharmaceutical regulations and industry best practices, ensuring organizational compliance.
• Manage vendor qualification and quality agreements to ensure the quality of supplied materials and services.
• Prepare and present quality metrics and reports to senior management.
• Champion a strong quality culture throughout the organization.
• Participate in product development and process improvement initiatives from a quality perspective.

• Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 8-10 years of progressive experience in pharmaceutical quality assurance and quality control, with at least 3-5 years in a managerial role.
• Extensive knowledge and practical experience with GMP regulations and guidelines.
• Proven experience in managing and implementing QMS.
• Demonstrated success in leading regulatory inspections (FDA, EMA, etc.) and managing audit responses.
• Strong understanding of pharmaceutical manufacturing processes, analytical testing, and validation principles.
• Excellent leadership, communication, problem-solving, and decision-making skills.
• Proficiency in data analysis and report writing.
• Experience with quality risk management principles.
• Ability to work independently, manage priorities, and lead a remote team effectively.

• 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.