Senior Director, Regulatory Affairs, Oncology/Cardiovascular

Gilead Sciences - Foster City, CA

Posted 833 days ago
  • Experience
    Executive
  • Job function
    Other
  • Employment type
    Full-time
  • Industry
    Biotechnology, Pharmaceuticals
  • Employer job ID
    Req 9637
  • Job ID
    3175400

This is a preview of the Senior Director, Regulatory Affairs, Oncology/Cardiovascular job at Gilead Sciences. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

Senior Director, Regulatory Affairs, Oncology/Cardiovascular

 

This senior level position will have a high level of visibility both with Research and Development based in Foster City, CA and with the International Organization based in Stockley Park, UK.

 

Relocation assistance is available.

 

 

CORE RELATIONSHIPS

 

Must be able to facilitate effective interactions within Regulatory, as well as with other departments and sites within the company (Clinical Research, Medical Affairs, Safety, Legal, Commercial operations) and Gilead affiliates, distributors and partners.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

 

Lead the Regulatory Affairs Function in Support of the Respiratory, Cardiovascular, Inflammation, and Oncology Therapeutic Areas at Gilead Sciences Headquarters in Foster City, CA.

 

Has responsibility for the following activities:

 

  1. Oversight of global regulatory strategy in support of Oncology, Inflammation, Cardiovascular, and Respiratory development programs and marketed products.
  2. Oversight of FDA interactions for above Therapeutic Areas.
  3. Oversight of multidisciplinary teams preparing NDA submissions and subsequent maintenance activities.
  4. Review and approve Regulatory documentation for submission to Regulatory Authorities.
  5. Responsible for advising the company of any changes to the regulatory requirements, legislation, or guidances that will have a potential impact on Gilead.
  6. Initiate, coordinate or contribute to local and/or global regulatory process improvements.
  7. Actively engage in the personal and professional development of your team.
  8. Regulates Budget planning and control for Regulatory Departments.

 

 

CORE COMPETENCIES

 

  1. Excellent oral and written communication skills.
  2. Ability to work both within the group and across groups.
  3. Demonstrated effectiveness in cooperation and teamwork skills
  4. Judgment/problem solving skills.
  5. Analytical and assessment skills.
  6. Planning and information seeking skills.
  7. Attention to detail.
  8. Ability to understand and effectively relate to external and internal customers.
  9. Good working knowledge of computer technology.
  10. Knowledge of regulatory requirements, including ICH and regional requirements and have an understanding of current global and regional trends and be able to assess the impact of these requirements on the business.

 

KEY ROLE-RELATED COMPETENCIES

 

  • Leadership
  • Business understanding
  • Impact and Influence
  • Strategic thinking
  • Managing for operational efficiency
  • Business awareness
  • Developing others
  • Positive approach to change

Desired Skills and Experience

EDUCATION AND/OR EXPERIENCE REQUIRED

 

  1. Proven ability over a substantial period in managing and developing a medium to large Regulatory Affairs group and successful product registrations.
  2. Typically requires a BA or BS degree, preferably in a scientific discipline, and minimum 15 years of relevant experience in related field. Or an MA, PhD or MBA degree and minimum 13 years of relevant experience representing Regulatory Affairs on project/submission teams.
  3. Must be capable of developing and implementing regulatory strategy and or managing complex negotiations with the FDA and Regulatory Authorities.

About this company

Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.   Gilead’s primary areas of focus include: HIV/AIDS, liver diseases, respiratory diseases, cardiovascular/metabolic diseases, inflammation and oncology. Our portfolio of 14 marketed products contribute to our revenue stream through direct or partner promotion.   Gilead was founded in 1987, the company has expanded rapidly over the past two decades, with annual total revenues exceeding $8.4 billion in 2011, operations spanning three continents (North America, Europe and Australia) with approximately 4,500 employees.

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