Sr Director Regulatory Affairs

Proclinical is currently seeking a Director/Sr. Director of Regulatory Affairs for a biotechnical company and immunotherapy manufacturing company. The Director/Sr Director of Regulatory Affairs is responsible for leading and participating on interdisciplinary regulatory teams responsible for defining and implementing regulatory strategy, including plans to submit Marketing Applications globally.

Job Responsibilities

• Provide regulatory strategy and support.
• Lead preparations and oversee submission of meeting materials for Global Health Authorities.
• Assess the impact of additions/changes to regulations and guidelines.
• Contribute to the development of department budget.
• Lead multidisciplinary teams in the authoring of regulatory submissions.
• Responsible for providing guidance, regulatory expertise, and advice to senior management and other company personnel.
• Develop materials for and lead key interactions with regulatory authorities.
• Define CMC regulatory submission strategies during development and post approval.
• Plan, manage and execute regulatory activities, including submission and maintenance of US and international regulatory filings.
• Evaluate potential licensing compounds and provide Company with CMC regulatory assessment.

Skills and Requirements

• BS/MS/PhD in a scientific discipline.
• 10+ years direct Regulatory experience in biotech or biopharmaceutical industry.
• Prior drug development experience.
• Experience with health authorities in China is highly desired.
• Pre- and post-approval experience with advanced cellular therapy products is highly desired.
• 5 - 7 years leadership experience.
• Knowledge of cGMP/ICH/FDA regulations.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 415-660-4945 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

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

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