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Associate Director, Regulatory Affairs - CMC

Parsippany, NJ

Posted: 07/24/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2402

Our client – a leading provider of non-opioid pain management and regenerative health solutions – is looking to add an Associate Director of Regulatory Affairs – CMC to their term on a permanent basis. In this role, you will provide regulatory expertise and lead regulatory projects.

Responsibilities include:
  • Coordinate, write and review CMC sections for regulatory submission to US and international health agencies in the areas of new drug development, marketing applications, life-cycle management submissions, formal meeting briefing package.
  • Ensure conformance to commitments made with various health agencies (e.g., IND/NDA/MAA commitments).
  • Assist in developing regulatory strategies; identify and implement appropriate submission strategies for assigned projects. Provide input for product labeling, CMC changes and clinical projects.
  • Coordinate the submissions and ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
  • Participate in Regulatory interaction and presentations to Regulatory Health Authorities, customers and partners.
  • Monitor and maintain awareness of regulatory environment assessing impact to business, interpret and disseminate information to affected departments.

Requirements / Qualifications:
  • Bachelor degree in life science from an accredited college or university
  • Minimum 8 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry
  • Demonstrated strong understanding of the U.S. and EU Regulatory requirements
  • Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements)
  • Excellent written and verbal English communication skills
  • Demonstrated excellent organizational skills
  • Proven negotiation skills
  • Proven ability to manage multiple projects, set priorities and meet deadlines
  • Excellent skill level in MS Office including Word, Excel and Outlook

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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