Regulatory Affairs Specialist at Merck Nigeria

Employment Nigeria 30-Mar-2018 NIGERIA , Administrative

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees in 67 countries work to further develop technologies that improve and enhance life from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions.

Job Title: Regulatory Affairs Specialist (Consumer Health, Nigeria)

Your Role

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.

What we offer
At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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Regulatory Affairs Specialist at Merck Nigeria

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