SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC

San Francisco Bay Area

Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs.

Independently manages all regulatory CMC business for oncology products throughout lifecycle.  Senior Director is responsible for the regulatory CMC strategy of submissions for all products as well as managing interactions with regulatory authorities on CMC issues.

Responsibilities: Develop, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.

• Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products making quality decisions.
• Manage interactions with FDA on CMC issues and develop global Regulatory contacts.

The successful candidate will be highly knowledgeable in US and global CMC Regulatory Affairs and have a track record of success in the drug approval process, strong interpersonal & leadership skills, and strong project management skills.  Compensation and benefits for this opportunity very strong.

Additional notes: Global Regulatory experience in Oncology is highly desired. Relocation is offered.