Vice President, Global Regulatory Affairs

15+ years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 10/15/17
Pleasanton, CA
15+ years experience
Biotech/Pharma
Salary depends on experience
Posted on 10/15/17

The Vice President, Global Regulatory Affairs will be responsible for all regulatory activities for Astex. In addition, the Vice President contributes to all company activities to ensure company objectives are met.

 

Responsibilities:

  • Develop and implement Regulatory and Development strategies and plans
  • Provide Regulatory strategy to support global CMC
  • Provide Regulatory strategy to support Clinical Development activities leading to registration
  • Select, mentor, and lead an effective Regulatory Affairs team
  • Plan content and timelines of regulatory documents and submissions to ensure alignment with agreed strategies
  • Proactively identify regulatory issues and provide solutions to keep our programs on time, while  maintaining the highest quality
  • Lead multidisciplinary efforts to produce INDs, NDAs, and ex-US filings
  • Lead global collaboration with parent company and other affiliates
  • Take a lead role in all Regulatory Agency meetings
  • Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports, Orphan Drug Applications, and Background Documents for Regulatory Authority meetings
  • Communicate directly with regulatory authorities to expedite submissions, their review and approval
  • Work with contract organizations to prepare applications, respond to queries, and maintain our clinical activities outside the USA
  • Assure compliance with regulatory standards and guidance
  • Maintain knowledge of the current regulatory environment, and interpret and communicate relevant issues to colleagues

Qualifications:

  • PhD in life sciences or PharmD
  • Minimum of 15years’ pharmaceutical Regulatory experience
  • Oncology drug development experience is highly desirable
  • Familiarity with global regulatory requirements and a history of successful interactions with regulatory authorities in North America and Europe; Asia experience is a plus
  • Extensive submissions experience at the IND and NDA stages
  • Flexibility and the ability to prioritize and handle multiple tasks simultaneously
  • Broad background and ability to work across multiple functions
  • Effective oral and written communication skills
  • Exceptional leadership and team management skills

17-23R

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