Expiry Date: 31-10-2023
Category Regulatory Affairs
Job Type: Full Time
Location: Boston, MA, or remote if working on EST
If you are looking for a role with an established Bio/Pharma company with a strong and diverse pipeline, offering strong packages, with a history of innovation in CMC and new formulations and modalities, where you will operate as the Director, Global Regulatory CMC lead on your projects (in both early and late-stage development), then this could be the role for you!
We are now recruiting for an experienced Regulatory Affairs CMC Director for a Global Regulatory CMC Lead role where you will be the strategic representative and matrix lead for Global Regulatory CMC, for products starting from Phase 2, providing regional and global strategic and operational regulatory CMC expertise through to initial NDA/MAA and in preparation for further global submissions (including Japan, China, Brazil).
Our client is a Global Bio-Pharmaceutical company with a successful recent history in bringing innovative therapies for neurological and rare diseases to global markets. They are leaders in many ways and their creativity in matching new formulations and combination products to their marketed product range has given them a unique advantage in expanding the range of products they can bring to all major Global markets.
At this organization, the Regulatory CMC team is a major strategic partner, which means their regulatory CMC roles are focused on providing both regional and global strategic expertise in both early and late-stage development programs.
As the global regulatory CMC lead, you will manage regulatory submissions for assigned compounds in several phases of clinical development and for initial global marketing applications (US/EU/China/Japan/Brazil) in line with the overall global regulatory product strategy. You will represent Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.
You must have proven leadership experience and the ability to work cross-functionally and across cultures with strong communication, excellent regulatory CMC knowledge, and competence in leading cross-functional teams, operating within a matrix organizational structure.
The package for this role is exceptional and includes a strong basic salary, bonus plus stock with a good vesting period. The position can also be fully remote, with some occasional travel requested to the HQ on the East Coast in Boston, MA on EST (but not frequent).
If you are interested in hearing more about this role, please contact me - Theo Moore on US 587.216.9302 or press the red “Apply for position” button and I will reply by return. We will support you throughout the interview and onboarding experience.