Regulatory Affairs Associate at RS Hunter Limited

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)