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Astellas Pharma Regulatory Affairs CMC Manager in San Francisco, California

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

Regulatory Affairs CMC Manager will support and independently manage global activities for all regulatory aspects (from a CMC perspective) of product development. This position will provide input into the product strategy and to the direction provided to the clinical teams as well as to the quality, manufacturing process development and analytical development organizations

The responsibilities include the following:

  • Independently prepare, draft, and coordinate high quality regulatory submissions (IND and CTA) and related maintenance documentation (responses to information requests, amendments, supplements, annual reports, safety reports, etc.) for US and other Regulatory Health Authorities within a defined time schedule.

  • Regulatory assessment of proposed manufacturing changes for global impact and providing strategic regulatory guidance for implementation of changes.

  • Represent the Regulatory Affairs CMC function on assigned cross-functional project teams and assume an integral member of the CMC subteam. Serves as single point of contact representing RA CMC for external CROs.

  • Independently design regulatory CMC strategy for programs.

  • Develop collaborative relationships with internal functional teams (liaise with regulatory clinical and regulatory operation teams.

Qualifications and Requirements

  • 5-7 years of experience in Regulatory affairs, CMC or related discipline in the pharmaceutical or biotechnology industry.

  • Bachelor's degree in scientific field, preferably Chemistry or Pharmacy is preferred; advanced degree is highly desired

  • Experience in management and filing of IND, CTAs, CMC amendment and variations to US and/or EU; BLA and Marketing Application filing desired.

  • Proven ability to lead cross functional CMC teams on projects and subteams.

  • PC literacy required; proficient use of technology including MS Office skills (Outlook, Word, Excel, Powerpoint, MS project and Internet resources is expected).

  • Strong knowledge and application of FDA regulations and cGMP requirements.

  • Must be able to work independently with minimal supervision

  • Excellent organizational, interpersonal and communication skills (oral and written)

  • PC literacy required; proficient use of technology including MS Office skills (Outlook, Word, Excel, Powerpoint, MS project and Internet resources is expected).

#LI-LK

Category CMC

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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