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 snr director to take the lead as the GRL in a role that will utilize your experiences in the US and EU for the development of NMEs in parallel from Phase 1b and 2a into pivotal studies. You will have ownership of the development of regulatory strategies and the opportunity to take advantage of new data, in a company where the LT is very regulatory aware and have a successful track record in developing and commercializing well-known brands for medium and large pharmaceutical companies.

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.

Experience needed:

You will have strong US regulatory experience plus knowledge of the EU regulatory framework and be happy working in early development for the next couple of years (the NMEs will go to late-stage data pending, around the end of this timeframe).

You will be someone who is reliable, dependable, and engaging, however, someone who also can give advice and change the consensus based on smart strategies and quantifiable risk-taking by working with the stakeholders to advocate your strategies (you will find they encourage this).

It’s essential that you managed and led full-spectrum global clinical trials and regulatory submissions, directed regulatory strategy, and worked collaboratively with the FDA, and with contract research organizations. Experience in Orphan and / or rare disease indications would be advantageous, as would experience in working in early development, so Pre-IND to P2.

Location & Package:

My client will allow fully remote working for any individual on the East Coast to Central Time or Midwest. Additionally, you will be encouraged to spend some days a month on site (during peaks), not because of dictate but because they think it is important to spend time with each other, attend global project meetings or plan for FDA or EMA regulatory meetings.

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 Theo@Advtalent.com or reach out to my colleague Ivan Nash on +1-908-378-8980.