Full-time Regulatory Affairs Specialist at Merck
A career at Merck is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Job : Regulatory Affairs Specialist
Job Status: Full Time Job,Graduate/Exp
Ensuring compliance of the local Merck CH product portfolio with applicable regulations, guidelines and Merck standards, set up and implement regulatory strategy regarding the local Life Cycle Management and local registration of new products, plan and coordinate the preparation & submission of registration and compliance dossiers. Follow and achieve registrations for the product portfolio according to plan, advise organization of potential regulatory risks in normal day to day activities and recommend compliant actions, review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements, liaise with health authorities, distributors, regulatory authorities, trade associations and contract manufacturers in the countries, in order to achieve and maintain registrations, develop relationships with regulatory and industry bodies in order to represent the interests of the organization, gain relevant information and help shape change, provide relevant regulatory advice in product development projects, keep abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional and local environment in order to ensure organizational compliance.
Who you are:
- Bacheler’s degree in health-related science, life science, pharmacy or medical degree (3-4 years university degree)
- Excellent in written and spoken English.
- In depth technical regulatory knowledge in the area of pharmaceutical development, OTC and Rx product, medical devices, food supplements, and demonstrated thorough understanding of regulatory requirements for countries under responsibility (Nigeria and Ghana)
- Proven track record in getting registrations approved in Nigeria and Ghana
- Experience in working across a wide range of regulatory systems and databases (> 2 years)
- Strong intercultural and problem solving skills
- Strong team-working skills – working across cultural and functional boundaries.
How To Apply