Gilead Pharmaceuticals is recruiting to fill the following vacant positions:
- Regulatory Affairs Specialist
- Senior Operations Executive (Pharmacy)
Regulatory Affairs Specialist Job Vacancy at Gilead Pharmaceuticals
Job Title: Regulatory Affairs Specialist
- 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
- 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 CV’s/Applications to: email@example.com
Note: Only shortlisted Applicants will be contacted.
Application Deadline 10th October, 2016.
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