Regulatory Affairs, Associate Director *** US & EU strategy for early dev. Rare Disease Projects *** Growing pipeline, strong team, exciting time to join! ** Greater Boston (Hybrid)

Reference: JPC588

Expiry Date: 31-03-2024

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

Salary: Competitive

Job Type: Full Time

Middlesex County
United States


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

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Job Description

Our Client: Currently we are supporting the growth of an exciting Biotech with a groundbreaking development platform and a good pipeline of early-development compounds for a number of high-profile rare genetic diseases. The organization continues to steadily grow and expand in both people and indications, and this role will work closely with a strong and engaging leadership team who have fostered a positive and collaborative working environment, and a strong sense of togetherness.

We think this is a great role where you will be working on several rare disease indications with huge potential. It’s a growing company with currently 300+ people onboard, and this is set to continue to increase. You will have high levels of autonomy and great visibility within an organization where you will be recognized for your contributions.

The Role: We are looking for a well-qualified regulatory affairs Snr Manager or Associate Director  to take a leading role for both US and EU strategy and submission activities in a broad-based and varied role that cover early development through to NDA/BLA/MAA. This a pure development role, where you will be supported by a strong and established regulatory team who enjoy the collaborative and engaging culture and are a good cohort of positive thinkers and doers.

You will enjoy working with the science not just the regulations, in a company where many of the senior executives are also working on the Global Project Teams. The role reports to a positive and straight-talking, highly strategic leader who has led the development and filing of several major drugs/indications/brands and will mentor, support and guide you through the twists and turns of global development projects.

You will have ownership of the development of regulatory strategies and the opportunity to take advantage of new data, in a company where the Leadership Team is very regulatory aware and have a successful track record in developing and commercializing well-known brands for medium and large pharmaceutical companies.

Experience needed: You will have strong US regulatory experience but also be keen to learn more about the  EU regulatory framework and be happy working initially in early development but ready to move with your projects when they move into late stage development.

You will be someone who is energized, motivated, creative and reliable, who can give advice but also take on feedback from senior stakeholders. You will enjoy building consensus and understand the concept of quantifiable risk-taking.

It’s essential that you managed or led PIP, Orphan and some aspects of Scientific advice meetings.  Experience in rare disease indications would be advantageous, as would experience in working in early development, so Pre-IND to P2.

Location & Package: My client is based in Greater Boston and operate Hybrid model of 2-3 days a week on-site. The package is commensurate with the grade and comes with both annual and joining stock / stock options, as well as a decent performance bonus.  The salary range is competitive and in line with Greater Boston packages.

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