Associate Director, Regulatory Affairs/GRL for Rare Diseases *** From Pre-IND/CTA to NDA/BLA/MAA ** Near Boston, MA

Reference: JPC586

Expiry Date: 31-03-2024

Categories Biotech, Clinical Research, R & D, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Suffolk County
United States


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

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Job Description

Our team is currently recruiting for a clinical-stage drug research and development organization led by an impressive senior executive leadership team. This is a smaller, well-funded biotech, which already benefits from the ongoing financial support of several Big pharma for the co-development and co-commercialization of several drugs in the pipeline. The company has great data readout on their projects in development across a range of rare genetic diseases and with their own in-house GMP manufacturing capabilities, they can move to clinical phases much more readily.

The organization is led by experienced individuals in all sectors, all from Big pharma, who have decided that working for a smaller and more agile company is their preference. The Regulatory team consists of passionate and innovative positive thinkers who love their work and they have fun doing it.

Our client is on the lookout for a Regulatory Affairs Associate Director / GRL to play a key role in the development of several early development programs. Are you someone experienced in early and late development, with direct experience of supporting NMEs? If so, you will be happy to hear that our client is open on therapeutic experience, as it’s the ideas and insight that you bring to the table that will be valued the most.

In this role, you will be reporting directly to a highly engaging, strategic, supportive and accomplished Head of Regulatory Affairs, who has made significant contributions to the development and filing of several major drugs. The company maintains a very welcoming culture, and you will quickly get the sense that everyone is both driven and pulling in the same direction. The teams and individuals work very hard and smart and are always encouraged to voice their opinions and/or concerns, in what could easily be described as an entrepreneurial environment, where everyone is committed to the patient and is always happy to lend a helping hand to reach quality results on time.

Do you crave autonomy in your work, and want a role with simpler reporting structures?
Do you prefer working and interacting closely with the leadership team, with fewer layers to go through before your ideas and recommendations can be heard? Then this might be the role for you!

The position is open to Senior Manager and Associate Director level candidates and comes with a competitive salary and a great company benefits package.

If you are interested in hearing more about this or other roles in Regulatory Affairs, please contact me, Theo Moore on 587.216.9302 or via email