Job Description

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

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. 

The Role

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.

Activities

• Providing regional and global strategic and operational regulatory CMC expertise and supporting cross-functional teams
• Leading the preparation and delivery of regulatory submissions (INDs/IMPDs/CTAs/NDAs/MAs)
• Providing strategic regulatory guidance to drug development and registration projects
• Writing and/or reviewing regional and global CMC submission documents and responses to Health Authority questions
• Lead Agency Interactions by successfully communicating and negotiating with international Health Authorities, directly and indirectly
• Leading reviews as required to ensure complete, concise, and accurate submissions to Health Authorities in assigned regions.

Experience Needed

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 10+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred
• Ability to deal with issues of critical importance, provide regulatory advice, and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
• Demonstrated leadership, problem-solving ability, flexibility, and teamwork
• Good judgment in elevating and communicating actual or potential issues to line management
• Excellent written and oral communication skills.

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).

To Apply:

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.