Regulatory Affairs Senior Associate

Regulatory Affairs Senior Associate

Led by a tenured, collaborative leadership team, my client is considered one of the premier branded and generic pharmaceutical companies in the United States. They are looking for a Senior Associate of Regulatory Affairs to be instrumental in managing programs that fall into the pre-approval activities. You will be responsible for coordinating the compilation, review and submission process for Pre Approval submissions, including SPL/PLR, including all interactions and communications with the FDA. This is a great opportunity to work within a company with a solid work/life balance and rapid growth in the upcoming months.

 

Responsibilities:

  • Contribute in the development of NDA and ANDA’s within pre-approval stage(s) in support of eventual filings
  • Communicate with R&D Formulations, Technical Operations, Analytical R&D, Manufacturing, Quality Control, Quality Assurance and the company’s internal audit group throughout the development and submission process to ensure all submission related documents are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently
  • Communicate and effectively follow-up with the FDA on various regulatory issues
  • Interact and communicate with Project Management on submission and project time lines
  • Utilize and remain current with internal/external electronic submission initiatives
  • Prioritize work flow to maximize efficiency

 

Knowledge and Skills:

  • Minimum BS in scientific discipline required; advanced degree preferred
  • Minimum 5-8 years’ experience in regulatory affairs
  • Knowledge of government regulations, policies, and procedures required
  • Must have a clear demonstration of regulatory training and capability
  • Must have contributed to the development of ANDA’s and NDA filings based on pre-approval activities
  • Must have a conceptual understanding of regulatory guidelines
  • Must have excellent problem solving skills
  • Polished communication and written skills a must

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