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Executive Director Regulatory Affairs

I am excited to announce that we are partnering with another biologic oncology company who has a multi stage and deep pipeline of products that they are trying to bring to market. If your looking to join a company who is on the verge of several approvals with more promising products in development for you to take ownership over, now is the time to apply!

This is a hybrid position, 3 days onsite in South San Francisco where you will be a key part of the Regulatory Affairs team and working cross functional with other department heads as well as other sites around the US.

Another exciting aspect of this position is the ability to oversee the growth and management of the Regulatory team, again giving you a chance to make this your own.

Responsibilities

• Possess comprehensive knowledge of regulatory requirements for the US, EU, APAC, and ICH, and effectively apply this knowledge strategically and operationally to development projects and regulatory issues for marketed products to support corporate objectives
• Supervise the preparation and submission of documentation to support investigational and marketing registration packages globally, ensuring adherence to timelines
• Review sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, ensuring compliance with local regulatory requirements
• Train, develop, and manage a proficient regulatory team through both direct and indirect reporting structures
• Establish partnerships with senior stakeholders from other functions to meet strategic business goals through the sharing of knowledge, expertise, and resources

Requirements

• Demonstrated strong leadership skills with the ability to manage, develop, and empower employees effectively
• In-depth understanding of drug development processes, the pharmaceutical industry, and the healthcare environment, including regulatory requirements and policy trends
• Extensive regulatory experience with INDs/CTAs, BLAs/MAAs, lifecycle management, interactions with regulatory agencies, leading and managing regulatory teams, and developing and implementing regulatory strategies, with a proven track record of significant regulatory achievements

Qualifications and Experience

• Ph.D. with 10 years of experience in pharmaceutical regulatory affairs, or B.S./M.S. with 12 years of experience in biotech or pharmaceutical regulatory affairs

If you would like to set up an introductory call please Easy Apply below or contact me directly on 919-647-9154 or at Charman@barringtonjames.com