Regulatory Affairs Specialist at Gilead Pharmaceutical Limited

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