Senior Director/Executive Director RA CMC

Proclinical is currently recruiting for a Senior Director of RA CMC with a leading biopharmaceutical company located in San Francisco, CA. As the Senior Director, you will be responsible for all CMC-related submission planning and for ensuring that high quality and accurate submission documents are completed within target timelines.

Job Responsibilities:

• Leads the development and implementation of all CMC regulatory strategy to support global development programs, and market applications for cell therapies.
• Responsible for ensuring the appropriate execution of CMC regulatory strategy.
• Actively seeks out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning.
• Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions.
• Lead the preparation of risk assessments on CMC regulatory topics.
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
• Stay current with regulatory requirements and initiate process improvements as appropriate.
• Analyze and exercise judgment on complex issues, guided by a thorough understanding of CMC.
• Other duties as assigned.

Skills and Requirements:

• Minimum 15 years of relevant Biologics experience in Regulatory Affairs CMC.
• Experience in Biologics drug development, market applications and commercial lifecycle.
• Bachelor's degree in a relevant scientific discipline, advanced degree preferred.
• Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA.
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

If you are having difficulty in applying or if you have any questions, please contact Nick Walker at (+1) 646-367-2908 or n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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