Senior Director, Regulatory Affairs, CMC
Company: Agenus
Location: Berkeley
Posted on: January 20, 2023
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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
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