Senior Manager, Regulatory Project Management

Location: Foster City, California US


This position is no longer open.

Job Number: 1896

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
Specific Responsibilities and skills for Position

The Senior Manager in Regulatory Project Management will be responsible for the coordination, prioritization and tracking of regulatory activities and submissions associated with the company's research, development and post-marketing activities for a variety of therapeutic areas. Regulatory activities may include support for both products in early and late stage development and marketed products.

Essential Duties and Job Functions

  • Develop and maintain detailed timelines for global regulatory activities and submissions for assigned therapeutic areas in major markets and ensure planning and coordination of activities via the Regulatory Submission Team.
  • Foster effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Regulatory Project Team.
  • Ensuring regulatory submissions are prepared according to defined Corporate or Regulatory timelines.
  • Working with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
  • Tracking regulatory commitments and timelines for maintenance activities such as Post-marketing Commitments and Follow-up Measures, and ensuring appropriate submissions are made in accordance with applicable requirements and deadlines.
  • Strategic oversight of one or more therapeutic areas
  • Current individual contributor with Managing at least one direct report, as appropriate
  • Will initiate or contribute to local and global process improvements within Regulatory Affairs department and cross-functionally which have a significant impact on the business and work collaboratively with other functional areas and Regulatory Affairs' functions at other sites (including the UK and Canada).

Knowledge, Experience and Skills
  • Excellent verbal, written, negotiation and interpersonal communication skills are required. Excellent organizational skills and ability to work on a number of projects with tight timelines is required.
  • The Senior Manager in Regulatory Project Management will ideally have a modest knowledge of regulatory requirements specific to key regions such as the US and EU and have a general awareness of current global and regional trends in Regulatory Affairs.
  • 8 to 10 years of relevant experience are required; experience in both Regulatory Affairs and Project Management is sought, and a BA degree in a relevant discipline.
  • An advanced degree and/or PMP certification is preferred.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0014505

Community / Marketing Title: Senior Manager, Regulatory Project Management

Location_formattedLocationLong: Foster City, California US