Senior Director, Regulatory Affairs, CMC

Company: Agenus
Location: Berkeley
Posted on: January 20, 2023

Job Description:

Senior Director (M6) - RA CMCThe incumbent is responsible for hands on oversight and support of CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs (RA) activities for antibody directed cancer therapeutics. -This role will provide expert guidance and evaluation of CMC content from an RA perspective to support a range of regulatory submissions in the US and globally. - Oversight and input will of necessity involve Module 3 content gap assessments, strategy and tactical approaches to presentation of information. - Submission types include annual reporting through to marketing authorisation applications in multiple regions. - A very strong technical background with demonstrable writing and verbal communication skills is a must. - Due to the type of content and complexity of information involved, an advanced scientific degree (i.e., MS or PhD) is highly preferred in conjunction with 10 years of progressively responsible RA and RA CMC support from a global perspective.. - -In general, the successful candidate will:* Develop and provide strategy, vision and direction to multiple functions. -* Implement companywide policies and practices. -* Provide input to executive management. -* Be accountable for function financial results which impact organization performance (within the context of RA CMC).* Work consistently with abstract ideas or situations across functional areas of the business. -* Provide thorough assessments of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for multiple functional areas. -* Anticipate factors that could influence strategies and company position in the market.* Establish and develop broader company strategy and translate that strategy into multi functional objectives. -* Identify potential strategic/tactical decisions that will affect the company's success for the next five years or longer.* Interact with internal and external executive level management, requiring negotiation of extremely critical matters Influences policymaking and strategy based on communication strategies and persuasion skills. -* Partner with executive leadership team for the function to provide cohesive direction towards company goals. -* Be recognized as an influential leader.* Develop and Oversee a team(s) to solve company-wide (including affiliated companies) matters RA CMC.

Keywords: Agenus, Berkeley , Senior Director, Regulatory Affairs, CMC, Executive , Berkeley, California