Executive Director, Regulatory Affairs

Executive Director, Regulatory Affairs

About the Company

Successful bio-pharmaceutical company with a global presence

Industry
Pharmaceuticals

Type
Public Company

Founded
1891

Employees
10,001+

Categories

• Pharmaceuticals

About the Role

The Company is seeking an Executive Director for Regulatory Affairs with a focus on Chemistry, Manufacturing, and Control (CMC) for Biologics. The successful candidate will be responsible for leading a team of CMC professionals and ensuring the development and implementation of global CMC regulatory strategies for late-phase new modality biologics products. This role is pivotal in driving alignment and execution across various global teams to meet the company's business needs and ensure compliance. The Executive Director will also be involved in managing significant projects, providing critical reviews of major submission documents, and effectively communicating CMC regulatory strategies to various stakeholders. A key aspect of the role is to establish strong cross-functional partnerships and to influence and negotiate with internal and external parties, including regulatory agencies. Candidates for this position should have a minimum of 15 years' experience in the pharmaceutical industry, with at least 10 years in regulatory CMC, and a strong preference for those with direct experience in antibody-drug conjugates (ADCs). The role requires a leader with a proven track record in global program management, post-approval strategy, and a minimum of 7 years in people management. The ideal candidate will be recognized as a leader in CMC regulatory strategy, with the ability to anticipate and influence within and across divisions. A B.S. degree in a relevant field is required, with an advanced degree (PhD preferred) in biologics, pharmaceutical sciences, engineering, or related areas. The Executive Director will be expected to demonstrate the ability to make rapid, disciplined decisions, and to drive the development of innovative solutions while managing a high-performing team.

Hiring Manager Title
Associate Vice President Regulatory CMC

Travel Percent
10%

Functions

• Legal
• Operations