** Regulatory Affairs Snr Director / GRL ** Do you want more autonomy for early dev. programs? Join a growing company with a good pipeline!

Reference: JPC587

Expiry Date: 30-09-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Location: HQ is based in Greater Boston, MA, but role can be fully remote if you are based on the East Coast or Mid-East.

Our client company is a clinical-stage drug research and development organization led by an impressive senior executive leadership team. They are a smaller biotech, but very well-funded and their development platform offers huge scope for the development of indications across a range of rare genetic diseases, and with their own scalable, in-house GMP manufacturing capabilities, they can move to clinical phase much more readily.

The senior leadership team consists of experienced individuals in all sectors, all from Big Pharma, who have decided that working for a smaller more agile company is their preference. The Regulatory team is positive and energetic, and they work hard but they have fun doing it, they are also good cohorts of positive thinkers and doers.

Currently, our client company is recruiting for a Regulatory Affairs Snr Director / GRL to play a key role in the development of several early development programs. So, someone who has drug development regulatory experience in ideally early and late development, with direct experience in supporting NMEs using adaptive pathways would be ideal. They are open to therapeutic experience, it’s the ideas and concepts that you bring to the table that are most important.

The role directly reports to a highly engaging and highly accomplished Head of Regulatory Affairs, who has made significant contributions to the development and filing of several major drugs/indications/brands, and we rate as a positive and straight-talking, highly strategic leader.

The culture here is very welcoming, 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.

If you crave autonomy in your work, and want a role with simpler reporting structures, less red tape to navigate, working and interacting closely with the leadership team, with fewer layers to go through before your ideas and recommendations can be heard, then this could be the role for you!

Experience needed:

You will be a qualified leader in Regulatory Affairs with 12+ years in drug product development with exceptional knowledge of US FDA regulations, clinical program development for drug, biologic, and regulatory application planning and execution. You will also have experience in rare, orphan drug, breakthrough, and pediatric product development and will have led numerous New Drug and Investigational New Drug Applications. You will possess excellent communication and organizational skills, and will be adept at navigating complicated corporate and regulatory strategies.

The role is open to Director and Snr Director level candidates and comes with a competitive salary, a fully remote working model, 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 Theo@Advtalent.com or reach out to my colleague Ivan Nash on +1-908-378-8980.