Regulatory Affairs Associate F&N Category Innovation Manager Business Services Intern Program Support Intern

To contribute to the implementation, coordination and provision of regulatory support to the new products in Nigeria as well as efficiently manage product portfolio, information and documentation in a manner that is aligned with the business objectives of the Company.

Registration of allocated new products and dosages in Nigeria.
Filing of new indications for existing products
Managing a portfolio of products
Providing safety updates to package inserts and patient information leaflets.
Renewals and amendments to registration dossiers in Nigeria.
Product documentation Management.
Information management.
Coordinate GMP inspections.
Interaction and follow up with Regulatory Authorities and collaboration with internal & external customers.
Assist with compliance and general functioning of the department
Support local and corporate business objectives by active team work and interaction with internal colleagues and external contacts.
Contributes to Pharmacovigilance activities in Nigeria

Education and Required Skills:

Computer skills must include working knowledge of Word, Excel, Power point, and internet
Excellent verbal and written communication, including presentation skills
Meticulous with attention to details.
Interpersonal skills and ability to interact with internal and external customers
Understands customer and market trends, identifying and adopting best practices to constantly increase productivity
Forecasting and budgeting skills
Goal and results oriented, business acumen
Demonstrates a high level of energy, drive and personal responsibility to achieve individual goals
Analyses and solves problems by seeking and interpreting relevant data in a logical manner
Attention to detail, adopting methodical, systematic, organised working style whilst retaining sight of the bigger picture
Anticipates and embraces change, adapting behaviour to suit the situation.
Works as part of a team, respecting the opinions, needs and contributions of others.
Able to build relationships across departments and functions
Listens and considers other’s points of view with an open mind

 Working Relationships:
Internal: Sales team, Business Development and Marketing Department.
External: Regulatory Bodies ( NAFDAC)

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