Director, Global Regulatory CMC ** Remote ** Would you enjoy a full lifecycle role from early phase to Global NDA/MAAs ** Strategic and Hands-on ** SM and/or Bio **

Location

Suffolk, VA | United States

Job description

Job Description

RA CMC Director ** Remote  ** Lead regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations ** SM and/or Bio

Location: Full remote if in Eastern or Central time zones including New Jersey, Pennsylvania, Massachusetts, New Hampshire, Ohio, Florida, South Carolina, Texas, Illinois  + more

If you are looking for a role........ with a growing Biopharma with a strong and diverse leadership team, an expanding and innovative pipeline, in a high-level RA CMC leadership role that is pure development from early phase to NDA/MAA including global strategy and global HA interaction (FDA, EMA, PDMA), then this could be the position for you!

Our Client:

Our client is a smaller but growing Global Bio-Pharmaceutical company with an impressive, rare disease portfolio.  They are well-funded and have a diverse leadership team that focuses on successful and innovative collaboration, personal development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. At this organization, the Regulatory CMC team is a major strategic partner, which means the regulatory CMC team has a strong voice for both regional and global early and late-stage development programs. 

The Role:

As the Director of Global Regulatory Affairs CMC you will oversee the development and execution of regulatory CMC development and registration strategies for Small Molecules and/or Biologicals in both early and late-stage development. You will manage regulatory submissions for assigned compounds in several phases of clinical development and for initial global marketing applications in line with the overall global regulatory product strategy. You will represent Global Regulatory Affairs CMC in Health Authority meetings and preparation activities. This is a smaller but growing team so the position will include both strategic and hands-on elements.

The Ideal Candidate:

You will 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. You will know Global regulatory strategy and have hands-on experience in executing INDs/IMPDs/CTAs/NDAs/MAA’s.  You will enjoy working in a smaller company, in a collaborative and hands-on environment.

Responsibilities:

• Providing regional and global strategic and operational regulatory CMC expertise and support in cross-functional teams.
• Leading the preparation and delivery of regulatory submissions (INDs/IMPDs/CTAs/NDAs/MAAs).
• 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 salary and bonus for this role are competitive and the benefits are extensive. The position can also be fully remote, with some occasional travel requested to the HQ on the East Coast in Boston/Cambridge, MA on EST (but not frequent).

Please apply via the "apply here" button or please contact me Theo Moore on +1.587.216.9302 or email me via [email protected] 

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