Associate Director / Director Regulatory Affairs

Proclinical is currently seeking an Associate Director or Director of Regulatory Affairs for a clinical-stage biotechnology company, focusing on auto immune diseases and cancer. Successful candidate will be responsible for regulatory strategies and management of all worldwide regulatory submissions and responses. In this role, emphasis will be on proper strategic and operational planning, collaboration with development team members, and execution on all aspects of regulatory affairs.

Job Responsibilities

• Lead Regulatory Affairs activities with an emphasis on global regulatory strategy and lead the preparation, review and submission of documents to the FDA and other regulatory authorities.
• Work with multidisciplinary project groups in meeting established objectives; prioritize projects to meet internal and external deadlines.
• Function as primary liaison with health authorities and regulatory consultants.
• Manage the internal review and approval process for submissions and regulatory questions and responses.
• Manage internal meetings around regulatory submissions and maintain internal trackers and databases.
• Provide support for pharmacovigilance-related regulatory interactions.
• Build a Regulatory Affairs department, manage budgets and project timelines, identify and address gaps in planning and resourcing.

Skills and requirements

• BS in life sciences, chemistry, or related discipline, advanced degree preferred.
• Regulatory affairs certification a plus.
• 5+ years of hands-on Regulatory Affairs experience involving successful IND and IMPD submissions; experience in NDA/MAA submissions highly preferred.
• Experience in eCTD format and structure.
• Knowledge of both GCP and GMP regulations.
• Demonstrated excellence in regulatory liaison/strategy including a broad understanding of international regulations, processes and issues in drug development.
• Strong computer skills, including Microsoft Suite, MS Project, and Adobe Acrobat.

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.

#LI-AG1
#Regulatory