Principal Scientist (director) - Regulatory Affairs-cmc

Laboratory Animal Management Association

Rahway, New Jersey, USA
Base: $190,800.00 - $300,300.00; bonus/equity: ann...
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Cmc regulatory strategies for biologics
Preparation and submission of cmc sections
Global cmc guidelines regarding ind/blas
** The Laboratory Animal Management Association is seeking a Principal Scientist/Director in Regulatory Affairs-CMC to oversee the development and implementation of regulatory strategies for biologics products. Candidates should have extensive experience in biologics or vaccine regulatory CMC, as well as strong leadership and communication skills. The position offers a hybrid work model and a comprehensive benefits package. **

Job Summary

  • The Principal Scientist / Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance.
  • The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc Principal scientist in support of their assigned projects.
  • The salary range for this role is $190,800.00 - $300,300.00; The successful candidate will be eligible for annual bonus and long-term incentive, if applicable; We offer a comprehensive package of benefits.

Matching Summary

Match Score: 75

** The Laboratory Animal Management Association is seeking a Principal Scientist/Director in Regulatory Affairs-CMC to oversee the development and implementation of regulatory strategies for biologics products. Candidates should have extensive experience in biologics or vaccine regulatory CMC, as well as strong leadership and communication skills. The position offers a hybrid work model and a comprehensive benefits package. **

Salary

Base: $190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, compassionate and sick days

Skills & Requirements

Must-have

  • CMC regulatory strategies for biologics
  • preparation and submission of CMC sections
  • global CMC guidelines regarding IND/BLAs
  • regulatory submissions of INDs, BLAs
  • critical review of submissions
  • regulatory affairs and applies this understanding

Nice-to-have

  • creative and imaginative problem solving
  • flexibility in responding to changing priorities
  • negotiating skills with cross functional partners
  • additional language skills are a plus

Key Requirements

  • At least ten years of relevant experience
  • B.S. in a biological science, engineering, or related field
  • Proficient in English

Work Rights

Not specified

Tailored Resume

Cover Letter