Gilead Pharmaceuticals Job Vacancies- 2 Positions

Gilead Pharmaceuticals is recruiting to fill the following vacant positions:

  1. Regulatory Affairs Specialist
  2. Senior Operations Executive (Pharmacy)

Regulatory Affairs Specialist Job Vacancy at Gilead Pharmaceuticals

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 CV’s/Applications to:

Note: Only shortlisted Applicants will be contacted.

Application Deadline  10th October, 2016.

***NOTE***: Click NEXT to go to the next vacant position.

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