Posted on :
20 Jun, 2012
20 Jun, 2012
The Regulatory Affairs Associate will be required to:
• 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
We are seeking candidates with the following Qualifications:
• Pharmacy degree with a top academic performance grade.
• 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
Qualified Candidates should send CVs to [email protected] indicating the position applied for.