Africa
Application Closed

Consultant, Regulatory Affairs

Full-Time/Part-time
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About Market Access Africa

Market Access Africa is a mission-driven healthcare organization that works with the public, private, and third sectors to design and deliver transformational healthcare solutions for Africa. We envision an Africa where world-class healthcare is the standard, and where deep-rooted inequities are a thing of the past. To solve complex problems on the ground, we curate and advance bold ideas that accelerate access to the best innovations and appropriate solutions for Africa’s health systems. We are daring to raise the level of ambition for what is possible in African healthcare. We do this by partnering with organizations across the healthcare ecosystem to develop bespoke solutions that recognize and leverage the uniqueness and dynamism of the different African countries where we work.  

The Role

Market Access Africa (MAA) is working on several initiatives to simplify and strengthen the regulatory processes for healthcare products on the African continent. We are looking for a Consultant with proven professional regulatory affairs experience to support our growing portfolio of work in this area. The Consultant’s primary responsibilities will be to track regulatory processes for healthcare products at both country and regional levels and serve as a resource person on regulatory issues. The Consultant will also drive development of unique regulatory affairs technology products with the support of a Product Manager and a software development team.

We are looking for someone with outstanding project management, problem-solving, and communication skills with deep personal commitment to producing results. Prior regulatory affairs experience is required for this role.

What will you do?

  • Oversee the development and launch of a regulatory affairs product. This will include providing project management support and managing developers and external consultants
  • Gather information about the country specific regulatory requirements using different sources (regulatory intelligence database, contact with the regulatory authorities, internet, regulatory consultants etc) and maintain an updated inventory
  • Provide advice to clients on local regulatory requirements and submission strategies to be followed
  • Evaluate the application and interpretation of relevant regulatory legislation
  • Coordinate compilation, submission and follow-up on applications or product registrations/renewals
  • Keep Sponsor and relevant internal/external parties informed on regulatory submission and approval status in different countries
  • Provide advice and/or assistance related to the request of Scientific Advice and other Agency meetings
  • Track regional regulatory harmonization initiatives to identify regulatory cooperation, convergence, harmonization, reliance and work sharing activities
  • Provide technical support to regional regulatory bodies

What are we looking for?

  • University degree in Chemistry, Pharmacy, Biology, Medicine, Engineering or other Life Sciences, or equivalent with thorough experience in the pharmaceutical industry.
  • 3-7 years of regulatory affairs experience working in the area of regulation of medical products, production and control of health products including medicines, vaccines, and diagnostics
  • We are more interested in finding the person with the right aptitude and excitement for this role, rather than a predefined years or set of experiences, and so are open to a range of experience/seniority in order to find the right fit
  • Experience interacting with regulatory agencies on the African continent
  • Project management experience
  • Regulatory dossier submission experience.
  • Fluency in English and French. Other languages are an asset

Interested?

The Consultant can work remotely, but will ideally be located within a few hours of GMT to better align with the time zones of the rest of the team. This could be a part-time role – minimum 50%. Travel within Africa will be required for a period of up to 4 weeks.