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Regulatory Affairs Senior Manager - CMC, clinical, non-clinical

  • Job type Permanent
  • Salary US$130000 - US$170000 per annum
  • Location Gaithersburg, Maryland
  • Sector Regulatory Affairs

Pharmaceutical Company in Gaithersburg MD are looking for a Senior Manager Regulatory Affairs to focus on early development regulatory for their vaccines product line. It is a regulatory strategy focused role for early phase products working with an experienced regulatory team and cross functional team.

As well as leading and managing pre-IND and IND submission activities, you will be working directly with the FDA on submission work.

You will be responsible for leading CMC, clinical and non-clinical regulatory strategy and execution.

This is a permanent direct hire role where you will be based on-site in Gaithersburg MD.

If you do not live within commutable distance, there is a relocation package on offer.

Salary is depending on experience levels, ranging from $130-170K base salary plus bonus and equity.

Responsibilities:

  • Lead all regulatory activities including the development of regulatory strategies for assigned products or projects
  • Lead the preparation of regulatory submissions including but not limited to pre-IND and formal meetings with FDA, Health Canada, EMA and other regulatory agencies, INDs/CTAs, Annual Reports, BLAs, NDAs/NDS/MAs and supplements, and routine correspondence
  • Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices
  • Provide critical review of all documentation supporting regulatory applications
  • Plan, coordinate, prepare and lead meetings and teleconferences with regulatory agencies
  • Lead interactions with the FDA and other regulatory agencies.
  • Monitor applicable current and new regulatory requirements. Provide regulatory intelligence for project teams and product development plans.
  • Work closely with Regulatory Operations for timely submission of electronic and paper submissions.

Requirements:

  • 8 years of pharmaceutical regulatory affairs with experience with vaccines or similar products.
  • Experience writing and leading submission process for pre-IND and IND.
  • Experience with CMC, clinical and non-clinical regulatory strategy and execution.
  • Bachelors Degree

If you are interested and meet the requirements, please apply with your resume and Real Staffing will reach out to discuss

Sthree US is acting as an Employment Agency in relation to this vacancy.