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Senior Program Manager, Regulatory Affairs - 10194

Simply Biotech San Diego, CA
  • Expired: over a month ago. Applications are no longer accepted.

Senior Program Manager, Regulatory Affairs- Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we’ve got the right team for you! In this role, you’re responsible for the duties listed below.

Immediate opening for a Senior Program Manager, Regulatory Affairs in San Diego, CA who possesses:

  • Degree in Scientific Discipline and 5+ years of progressive Regulatory Affairs experience in Biotech or Pharmaceutical Industry
  • Experience with early development regulatory affairs (CMC, Clinical and Generalist Experience) CBER, NDA or BLA preferred experience
  • Domestic FDA experience required, EU preferred with authoring, coauthoring, reviewing and editing – strong regulatory writing knowledge

Email resumes to hyazalou@simplybiotech.com or call 858.496.7758

FULL DESCRIPTION:

The Senior Program Manager, Regulatory Affairs (RA) will provide support to the Executive Director, RA in the development and implementation of regulatory strategies for development products. This individual will support regulatory activities, including strategy development for programs and dossier lifecycle management, and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings. This is a full-time position located at our corporate headquarters in San Diego, CA.

The selected candidate will further possess:

  • Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly
  • Excellent operational skills including planning, organizing, and the ability to deal effectively with a variety of personnel both internally and outside the company to drive projects to timely completion
  • Excellent writing, communication, and interpretive skill
  • High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently
  • Previous cell therapy product experience and regulatory knowledge is highly preferred
  • Prior direct interactions with Health Authorities is desirable

The selected candidate will be responsible for the following:

  • Effectively work with internal and external stakeholders to independently manage regulatory activities
  • Manage, author, coordinate, and review regulatory submission documents and development activities to support regulatory filings and dossier lifecycle
  • Independently research and interpret regulations, and provide regulatory guidance and strategy to cross-functional stakeholders; monitor clinical, non-clinical, and CMC industry and regulatory trends and be able to apply learnings and provide guidance or strategy related to such trends
  • Lead and manage the strategy and preparation of health authority meeting materials and responses to requests for information
  • Support management with development and implementation of departmental strategies and policies, and contribute to the development and implementation of regulatory strategies to mitigate risks
  • Assure compliance with all applicable (domestic and international) regulations
  • May mentor or lead other department staff
  • Other duties as assigned

Working Conditions and Physical Requirements

  • May require occasional evening and weekend work
  • Full-time onsite work at Company’s headquarters in San Diego
  • May require occasional travel for training programs and meetings

For immediate and confidential consideration, please email your resume to hyazarlou@simplybiotech.com or call 858.496.7758

More information can be found at www.simplybiotech.com

Simply Biotech

Why Work Here?

Growing company with international reach. Opportunities for advancement and helping make life better for patients!

Simply Biotech specializes in recruiting exclusively for the biotech community.

Address

San Diego, CA
USA

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