Director, Regulatory Affairs Strategy
The Judge Group Inc.

Job Info

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Location: Paramus, NJ
Salary: TBD
Description: Our client is currently seeking a Director, Regulatory Affairs Strategy

Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related activities of assigned projects and manage direct reports, consultants and CROs to support US and ex-US investigational and marketed product submissions.

This job will have the following responsibilities:

• Serves as a liaison to FDA and provides strategic input to CROs and their regional regulatory leads responsible for ex-US regulatory activities. Provide oversight of regulatory consultants and vendors where applicable.
• Provides regulatory strategic support and guidance to assigned project teams.
• Performs research on regulatory precedence and competitive intelligence as needed.
• Contributes to identification of potential issues/gaps and proposes creative risk mitigation strategies to address gaps affecting optimal and timely submissions and approvals.

Qualifications & Requirements:

• Advanced degree strongly preferred (PharmD, MD, PhD) with 10 or more years of related pharmaceutical product regulatory experience in biotech/pharma branded industry including 5 or more years of new drug development experience.
• Experience managing regulatory CROs, consultants and or direct reports.
• Experience interacting with the FDA and ex-US health authorities
• Evaluate and improve internal processes for better utilization of external support.
• Assess and align RA activities/resources with R&D project needs.
• Monitor FDA Regulations/EMA Guidelines that are applicable to company's activities and provide to teams as applicable.
• Oversee and manage activities on assigned projects including on-going resource evaluation (including internal and external/consultants), building internal/external capabilities.

Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.