Advert View :: Company Pharmacist & Regulatory Affairs Manager | Nairobi | Pharmaceutical / Biotechnology

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Job Title

Company Pharmacist & Regulatory Affairs Manager




Advert Details

Recruiter: Armada Human Capital Updated on: 2017-09-21 08:33:56
Contract Permanent
Location: Nairobi Available: ASAP
Category: Pharmaceutical / Biotechnology Offer: Negotiable




Our Client is in the Pharmaceuticals Industry and is looking to recruit a Company Pharmacist and Regulatory Manager

Minimum Requirements





Job Specification


Regulatory Affairs:
  • Develop regulatory strategies to ensure alignment with commercial objectives/priorities, ensuring that key issues are appropriately addressed.
  • Develop and implement strategic programmes to drive timely registration of new and re-registration of existing products for Kenya and export markets.
  • Review registration dossiers for submission to regulatory authorities to ensure timely registration of products and manage these registrations in terms of re-registrations and notification and approval of changes done on the products.
  • Interactions and negotiations with regulatory authorities to deliver regulatory approvals to meet business needs
  • Shape the regulatory environment through proactive, innovative and leading edge interfacing with Regulatory bodies in Kenya and other export countries in line with our client's and international best practices.
  • Develop effective and professional relations with regulatory bodies and industry trade associations (both locally and internationally), recognising and reflecting regional and country diversity whilst keeping abreast of and effectively communicating information on regional and global harmonisation of standards, safety, labelling and other relevant practices.
  • Help challenge unfavourable pharmaceutical legislation. Network and establish influential relationships with national and international governments and trade associations, to achieve advantage for our client and the industry by helping shape the regulatory environment in Kenya and the region.
  • Monitor the regulatory environment and lobby for legislations that enhance commercial activities e.g. switches from one category to another (e.g. From POM to GSL category).
  • Provide strategic support and input into area and corporate programmes for the management of "access" initiatives. This means with liaising with marketing & sales department, Governments and Non-Governmental Organisations.
  • Work in partnership with Commercial and Medical to evaluate, strategize and exploit commercial opportunities by introduction of new pharmaceutical products relevant to these areas with high quality, competitive and timely plan and executions.
  • Provide commercial and technical support, including putting and ensuring quality (QMS) processes in place to manage compliance.
  • Provide commercial and technical support/input, where applicable, local legal Agreements to cover business activities.
  • Ensure labelling updates are managed in a timely manner to ensure compliant licenses.
  • Develop relationships with Key Opinion Leaders - Governments, Regulatory bodies etc.
  • Interact with Regulatory Authorities officials for develop relationships that are close, effective and of benefit to the organization.
  • Provide support on the review and approvals of promotional materials, artworks for labelling, etc.
  • Support the marketing function by providing guidance on safety issues relating to our client's products.
  • Provide support on Trademark and counterfeit issues.
  • Play key role in issues management e.g. product recalls, product related issues & complaints.
  • Crisis management champion on product related issues.
  • Media contact, when necessary, on all of our client's products and other product issues.
  • Company Pharmacist for our client's Kenya licences.
  • GMP Inspections, and managing this process (with QA. QC and Production) to ensure that GMP inspections do not negatively impact on product availability and our client.
  • Negotiate with Regulatory authorities on e.g. advertisement approvals, labelling, new regulations complaints and imports & exports to achieve commercial objectives.
  • Responsible for Product release and is in compliance with our client, GMP and Regulatory.
  • Responsible for submissions of quarterly returns for controlled substances and custody, documentation and control of these items and that other items as per Cap 244 and Cap 245. Regulations of Pharmacy and Poisons Boards.
Staff Development:
  • Support training and education programmes to ensure understanding and compliance of key regulatory processes.
  • Help develop and retain regulatory talent. Ensure a succession stream is developed for the long term.
  • Support training of marketing and sales personnel to understand role of regulatory function and the uses and actions of products.
  • Act as a resource to training department on product training, SOP training etc.
Product Compliance & Process Improvements/Safety and Pharmacovigilance:
  • Ensure Regulatory practices and procedures are in line with the Regulatory bodies.
  • Continuously examine and identify areas of improvements (e.g., resource utilisation, areas of rework, speed, cost, etc.) in the overall in the registration process to maximise process efficiency and deliver an improved service.
  • Ensure that consistent Regulatory practices are employed across the Pharmaceutical, Veterinary and Consumer business areas. Identify and share examples of best Regulatory practices.
  • Minimise our client's "risk" and ensure continuity of product supply by pro-actively managing compliance issues in accordance with corporate, regulatory and legal standards:
  1. Oversee the technical change procedure thereby ensuring that country product licences are in compliance with factory procedures.
  2. Ensure compliance with International and Local standards/processes and legal requirements for product labelling in local and International markets. Ensure safety information is accurately presented to prescribers and patients.
  • Responsible for Pharmacovigilance.
  • Overall responsibility for ensuring compliance with local regulations and, in conjunction with the relevant Health and Safety Committee in our client's company and for providing response to local regulatory enquiries.
  • Work closely with Marketing, Quality Assurance, F&D and Manufacturing in the development and introduction of new products in the region. 

How to Apply:

Interested candidates holding the necessary requirements, good performance and / or references are encouraged to apply with detailed CV's, inclusive of names and contacts of 3 referees, current telephone number and email address by clicking on: Company Pharmacist and Regularity Affairs Manager



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