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CMC Regulatory Affairs - $175K

  • Job type Permanent
  • Salary US$160000 - US$175000 per annum
  • Location Philadelphia, Pennsylvania
  • Sector Regulatory Affairs

CMC Senior Manager of Regulatory Affairs job for a pharmaceutical company in Gaithersburg MD. There is an option to work remotely 2 days/week if you do not live locally.

This is a new role for the company, as they are putting together a CMC center of excellence which you would lead. You would be responsible for managing CMC activity for biologics product lines across 4 sites. There is a wide range of products you would manage across multiple manufacturing sites in the US.

As the Senior Reg Affairs Manager you will lead strategy for all CMC changes in your product portfolio including facilities/equipment changes. You will work with cross functional teams to assess regulatory impact and advise accordingly, this includes submission processes as well as post market approval changes for commercialized and clinical products. You will interact directly with regulatory authorities and notified bodies.

It is a direct hire role.

Salary is depending on experience, ranges $160-$175K base salary, other incentives include bonus, equity and relocation package.

Requirements:

  • Bachelors Degree in the scientific, engineering or related industry
  • 10 years of regulatory CMC experience in the pharmaceutical industry
  • Experience interacting with the FDA and other notified bodies
  • Ideally would have experience with biologics based products

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