Job Description

We have a new Director of Regulatory Affairs CMC role open for a Top Ten Biotechnology company that we feel will be a great opportunity for someone who wants to manage both people and global projects.

The RA CMC Biotech group is well established, but continues to grow quickly, and the company has over 50 indications in development across Oncology, Haematology and Immunology for several exciting modalities - and is rated as one of the best in the industry.

As a result of their continued success and growth, my client is searching for a new Regulatory Affairs Director of CMC to provide global strategic leadership for products in early and/or late-stage development and for MAA’s/BLA’s in a role that also has direct people management and global strategic leadership and influence.

This role will suit an accomplished regulatory CMC leader with a proven track record of successful worldwide submissions (NDA/MAA/IND/IMPD/IDE/PMA), with comprehensive expertise in drug development, pre- and post-approval regulatory CMC guidelines, and global submission requirements for Biologicals.

You will be a proven people manager / leader with highly developed skills in teamwork, partnering, and collaboration, in complex and timeline constrained environments, happy to lead a team of up to 7 RA CMC Strategists, including remote locations (US and EU) on both a product and project support basis.

The role is based in NJ, with a good mix of home/office working and the salary and packages are also top end, including LTi’s/stock options with good vesting periods.

Experience needed:

• Proven ability to work effectively with Health Authorities (US FDA, EU EMA and Health Canada).
• Comprehensive expertise in drug development, pre- and post-approval regulatory CMC guidelines, and global submission requirements.
• Strong expertise in CMC regulatory dossier management, dossier strategy and content development.
• Direct people management and team leadership for at least 3+ people.

To Apply!

If you are interested this role or are open to something new in the Regulatory CMC space, please contact me, Theo Moore on Theo@AdvTalent.com or call US 908 348 6714 - We are available 8.30am to 6pm EST or can happily take a call over the weekend until 1pm EST. I will support you throughout the interview and on-boarding experience.

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