ASSOCIATE DIRECTOR / DIRECTOR, REGULATORY AFFAIRS – CMC

New Jersey

Our client, a global pharma company, has a new opportunity for an Associate Director / Director level Regulatory Affairs professional with CMC expertise in Central NJ, to help drive US and Global Regulatory projects. This is a full-time Associate Director / Director level role with a primary focus in small molecule development.  Independently manages all regulatory CMC business for drug candidates/products throughout lifecycle.  Associate Director / Director is responsible for the regulatory CMC strategy of submissions for all products marketed and in development, 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 which include planning, authoring, reviewing, coordination, submissions (NDA, BLA, MMA) and reports  for assigned projects/products, making quality decisions.
• Manage interactions with FDA on CMC issues and develop global Regulatory contacts, represent company with regulatory authorities
• Inspiring, engaged, effective, example-setting leader with an interest in developing and training regulatory staff.  Developing positive and effective relationships with CMC and regulatory team members, as well as external business relationships.
• Strategic in negotiations and developing the direction of development undertakings
• Advanced degree preferred

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 with a diverse pipeline of products is highly desired. Relocation is offered.