Expiry Date: 20-06-2025
Category Regulatory Affairs
Job Type: Full Time
Regulatory Affairs / Associate Director, Global Regulatory CMC Lead for Marketed Products, Boston MA
Regulatory Affairs Associate Director, Global Regulatory CMC Lead, based in Boston, Massachusetts for an expanding Biotech with a great pipeline.
ADV Talent partners have a role with one of the world’s most successful and highly regarded Biotechnology companies in the industry. With over 25 indications across their core therapeutic areas of Immunology and Neurosciences they are in a great position to continue their R&D success in 2020.
My client has a dynamic and exciting working environment and they are definitely considering one of the leaders in Gene Therapy. Regulatory is encouraged to have a strong voice across all development activities and they are always happy to train and develop team members to grow their expertise and to ensure you have the right balance between support, encouragement and the space to lead your own projects.
This is a new role (due to expansion) and the tech team is based here on-site in Boston. You will be
leading projects, teams and negotiations with the HA’s in strategic position, covering 2 major marketed products, initially for the US and LatAm, but with the remit to grow, to cover all major global regions including the EU, AP, and RoW. Both products come as a Combo drug + med dev (injection or a pen) and there are some major some activities happening with these products, including a number of new presentations and new routes of administration. You will matrix lead a number of local RA CMC Sr Managers around the world, as you devise and implement the overall strategies.
In the long term, this role will give you people leadership, global responsibility and the opportunity to move into direct people management or to move into early or late development for new products. Promotions are expected and encouraged!
On offer is a high remuneration package, with an industry high salary, bonus and stock options with a low vesting time.
To apply for this role, please hit the Apply button or contact Theo Moore on US toll free 855.505.1382 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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