Director/Sr. Director, Regulatory CMC

Director/Sr. Director, Regulatory CMC |  Seattle, WA | 

Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing. You will be joining at an exciting time when Just-Evotec Biologics is making game changing advances in biologics discovery, development and manufacturing. The primary responsibilities are to develop and execute global (with an emphasis on US and EU) CMC regulatory strategies towards regulatory adoption of innovative approaches to biologics product and process design, and manufacturing; to lead and manage CMC matters for internal and external products and programs.   The Director of Regulatory CMC will have oversight for planning, preparation, and execution of CMC-related communication and documentations for engagement with regulatory authorities. The successful candidate will possess strong interpersonal and team skills to advise and persuade internal and external stakeholders.

Responsibilities:

• With an emphasis for the US and EU, interpret global CMC regulations and provide strategic direction and regulatory guidance that are relevant to biotherapeutic technologies, products and systems being developed by Discovery, Process Development, Quality and Manufacturing

• Regulatory input on the design of the J.POD commercial multi-product and multi-modality manufacturing facility

• Coordinate appropriate meetings such as with the FDA Emerging Technology Team to discuss, identify and resolve potential regulatory issues regarding the design and operations of J.POD manufacturing

• Lead and coordinate interactions with global regulatory authorities to ensure acceptance, rapid review and approval of applications, supplements/variations and submissions which present CMC information

• Lead an coordinate authoring of submissions and/or sections of submissions with clients, in-house SMEs and consultants

• Lead and manage of Chemistry, Manufacturing & Controls (CMC) components for products in early-to-late stage development including novels,  biosimilars and cellular therapies

• Develop innovative strategies and provide Regulatory Affairs input for clients and business partners on all CMC related matters

• Assure Type V Master File, Letters of Authorizations, and Annual Reporting filings are maintained in accordance with regulatory requirements.

• Build and scale RA capabilities through creation of a right size internal team and leveraging of consultants and partners

Qualification and Education Requirements:

• BA/BS degree in molecular biology, cell biology, biochemistry, protein chemistry or similar.

• Minimum of 8 years of experience in Regulatory Affairs CMC

• Minimum of 10 years in related disciplines in the pharmaceutical or biotechnology industry in development, quality and cGMP manufacturing

Preferred Qualifications:

• 15+ years related experience with an advanced degree in related discipline

• Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, process development, quality and manufacturing.

• Experience collaborating with CDMOs, contractors and partners is a plus

• Experience with preclinical and clinical regulatory affairs topics

• RAC certification

The base pay range for this position at commencement of employment is expected to be $168,000 to $200,000;  Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.