Regulatory Affairs / Associate Director, Global Regulatory CMC Lead for Marketed Products, Boston MA (code USA 240120-1)

Reference: TM240120A

Expiry Date: 24-03-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Suffolk County
United States

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Job Description

Regulatory Affairs / Global Regulatory CMC Lead for Marketed Products, Boston MA

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!

Experience needed:

  • At least 8+ years relevant experience in Regulatory CMC and pharmaceutical manufacturing, analytical development or quality assurance/control.
  • Successful leadership in delivering CMC sections of marketing authorizations and post-approval submissions for new biological and/or chemical entities.
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
  • Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics.
  • Knowledge of global guidance, regulations and ICH/GMP requirements

On offer is a high remuneration package, with an industry high salary, bonus and stock options with a low vesting time.

To Apply!

To apply for this role, please press the red “Apply for position”, or contact Theo on 855.505.1382. We wish you a successful 2020 and fortuitous year! 

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