Director Regulatory Affairs CMC *** Small Team ***Expanding BioPharma ** Strategic and Hands-on Global Role **Lead IND/IMPD/NDA/MAA’s ** Fully Remote

Reference: 9927014

Expiry Date: 30-04-2024

Categories Biotech, Clinical Research, Manufacturing / Production, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
United States
Remote Working

Benefits:

  • Child Care
  • Dental
  • Flexible Hours
  • Medical
  • Life Insurance
  • Parental Leave
  • Retirement Plan
  • Sick Days
  • Vacation
  • Vision Insurance

Apply for position

Job Description

Location: Remote, with the Global HQ in Greater Boston, so EST or Central working hours.

This role would suit an experienced RA CMC professional who wants to work in a smaller team with less hierarchy and more focus on innovation and strategic leadership, who also wants an opportunity to lead both early and late-stage development projects!

We think this is a great role for a company with an exciting pipeline and great plans for expansion – this is a unique opportunity to join a growing Bio/Pharma that is well funded with an innovative pipeline and a collaborative and positive culture.

My client is looking for someone with a collaborative and team-oriented attitude and approach, who can foster effective and positive interactions across functions, project teams, and regulatory agencies as they continue down the road of growing their Regulatory CMC team to lead early development indications and prepare late-stage indications for NDA/MAA.

This is currently a small team in the US, but this position will be an important piece of the expected growth of the Regulatory CMC department. So, as well as taking a leading role as a Regulatory CMC strategist you will also be setting the structure for the growth of a new team to follow this year and next.

The Role:

As the Regulatory Director CMC, you will be responsible for managing the regulatory CMC aspects of assigned projects in early to late-stage development, as well as overseeing NDA/MAA submissions.  This is a wide and varied role including everything from strategy oversight and HA interactions to helping to formalize submission processes and development roadmaps.

You will be reporting to a strong and dedicated VP of Regulatory CMC who will be working with you to help shape and grow the new team build. The Regulatory Leadership team is well established and well respected, with many coming from the Top Ten Biotech companies on the East Coast.

On offer is a great overall package including high-level and very generous PTO, extensive benefits and a very competitive salary and bonus structure.  The working culture is relaxed and focused on strong and positive inter-department/cross-functional interactions.

We think this is an exciting role for an impressive organization and in the first instance, if you are interested in applying or discussing the role in more detail,  please call me, Theo Moore on 587.216.9302