Director, Regulatory Sciences

ProPharma

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7 years regulatory affairs experience
Fda regulations and guidelines knowledge
Team leadership and mentorship skills
** ProPharma is seeking a Director of Regulatory Sciences to lead and manage a team focused on regulatory strategies, submissions, and compliance for clients in the biotech and pharmaceutical sectors. The ideal candidate should have significant experience in regulatory affairs, strong leadership abilities, and a strategic mindset to drive the organization’s goals. **

Job Summary

  • The Director will lead and oversee projects for US Regulatory science clients while managing a team of professionals.
  • ProPharma partners with biotech and pharmaceutical organizations to de-risk and accelerate high-profile drug programs through an advise-build-operate model.
  • The role requires staying updated on relevant regulations and ensuring compliance while establishing effective relationships with regulatory authorities.

Matching Summary

Match Score: 75

** ProPharma is seeking a Director of Regulatory Sciences to lead and manage a team focused on regulatory strategies, submissions, and compliance for clients in the biotech and pharmaceutical sectors. The ideal candidate should have significant experience in regulatory affairs, strong leadership abilities, and a strategic mindset to drive the organization’s goals. **

Skills & Requirements

Must-have

  • 7 years regulatory affairs experience
  • FDA regulations and guidelines knowledge
  • Team leadership and mentorship skills
  • Strategic regulatory submission planning
  • Cross-functional collaboration expertise

Nice-to-have

  • Advanced degree in scientific discipline
  • Hatch-Waxman Act understanding
  • Proven track record of approvals
  • Innovative problem-solving mindset
  • Cost-effective resource allocation

Key Requirements

  • Bachelor's degree in scientific discipline
  • Minimum 7 years regulatory affairs experience
  • In-depth FDA regulations knowledge
  • Proven successful regulatory submissions history

Work Rights

Not specified

Tailored Resume

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