Associate Director Regulatory Affairs

2 months ago


Morristown, United States Germer International - Pharmaceutical Recruiting Full time

Are you interested in joining a well-established pharmaceutical company that has a broad portfolio of branded and generic pharmaceutical products? Our client is looking for a strong leader, who can develop and implement CMC strategy, while working directly with the senior leadership team.


Apply here or reach out to Jessica Goodman for more information


Qualifications:

  • Bachelor’s degree
  • 8+ years of work experience in US FDA regulated pharmaceutical development and manufacturing
  • Must demonstrate strong leadership qualities
  • Strong background in CMC documentation is preferred


Responsibilities:

  • Lead and manage a team of Regulatory Affairs professionals
  • Coordinate and review all regulatory submissions of the company including ANDAs and 505(b)(2) NDAs
  • Develop and implement regulatory strategies and filings throughout each product’s lifecycle
  • Manage regulatory risks and ensure compliance with all applicable regulations
  • Ensure regulatory and cross-functional project strategies and submission timelines are in alignment for successful filing and timely approval
  • Actively monitor changes in applicable regulatory requirements and industry trends, and proactively identify and propose solutions for potential regulatory challenges
  • Author and review departmental SOPs, as well as any other additional SOPs that may impact regulatory affairs



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