Regulatory Affairs Specialist At Gilead Pharmaceutical Limited

Gilead Pharmaceutical is recruiting for the following positions in Nigeria.

Job Title: Regulatory Affairs Specialist


Job Summary

Responsible for assisting the team with regulatory filings as necessary to market company products.
This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.
Duties and Responsibilities

Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.
Respond to requests from foreign government and/or distributors as needed
Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
Evaluate risk of proposed regulatory strategies; may offer solutions
Reviews proposed labeling for compliance with applicable global regulations
Writes and manages the development of package inserts
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Communicates with regulatory and governmental agencies with supervision
Education/Experience Requirements

Bachelor’s Degree required; concentration in Life Sciences, Technical/Engineering or related field, preferred
A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
Regulatory Affairs Certification
A combination of education and experience may be considered.
Areas of Competence:

Strong writing, communication, and interpersonal skills
Strong attention to detail; ability to multi-task and balance competing priorities
Knowledge of overall business environment and the marketplace
Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed based on functional area
Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
Ability to identify risk in Regulatory strategies
Strong problem solving skills
Effective negotiating skills
Basic computer skills, including Microsoft Office Suite

How to Apply

Interested and qualified candidate should forward their CVs/Applications to: gileadpharm@gmail.com

Note: Only shortlisted Applicants will be contacted.