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Senior Director, Global Regulatory Affairs

Bayside Solutions
Menlo Park, CA
  • Posted: over a month ago
  • Full-Time
Job Description

The Senior Vice President, Clinical Development will report to the Senior Director, Global Regulatory Affairs. You are a strategic contributor to our product development plan and will develop and implement US and global regulatory strategy for our programs. You will be in charge of building a direct report team and collaborating with our cross-functional teams to deliver on the mission of powering the next wave of genetic medicines.

Responsibilities:

  • Create and implement US and global regulatory strategies that are in line with business goals for the portfolio of genetic medicine programs in development.
  • Create, manage, and lead a regulatory affairs team to support the expanding development pipeline.
  • Senior management should receive regulatory strategy guidance, direction, and leadership.
  • Contribute strategically to product development plans from discovery to approval.
  • Be the primary point of contact for regulatory authorities in day-to-day interactions.
  • Maintain working knowledge of current US laws, regulations, and guidelines, as well as familiarity with the global regulatory environment.
  • Supervise the preparation of meeting requests, briefing documents, and meeting teams, as well as interactions with regulatory authorities.
  • Create and implement the global regulatory strategy, from IND/CTA to BLA, and collaborate with program leadership, clinical, nonclinical, CMC, quality assurance, project management, and other relevant functional areas to drive product development to successful registration and approval.
  • Develop and implement risk registers/mitigation strategies in accordance with corporate objectives, and plan and ensure regulatory compliance for assigned development programs.
  • Lead cross-functional teams in the preparation and review of regulatory documents, including but not limited to IND and amendment, BLA, safety reporting, periodic reporting, and responses to health authority questions, to ensure high quality and timely submission to health authorities.
  • Oversee labeling development as well as advertising/promotional review activities.
  • Lead regulatory interactions and meetings with health authorities such as the FDA, EMA, and MHRA, among others.
  • Changes in the regulatory environment, regulation, regulatory guidance, and regulatory guidelines should be monitored. Inform companies about the potential impact of these changes on their drug development programs, and adjust regulatory and risk mitigation strategies as needed.
  • Management has assigned additional project responsibilities to the support business.
  • Assist regulatory consultants and contractors in completing and/or managing all assigned responsibilities, such as regulatory project management and operations, on time.

Qualifications:

  • Advanced Degree (PharmD, PhD, MPH, or equivalent) in a scientific field preferred
  • 15+ years of Regulatory Affairs experience in the biotech/pharma industries
  • Rare disease/orphan drug experience, required
  • Regulatory experience across all phases of development from Pre-IND through BLA submission and approval, required. Prior experience of leading an IND and a BLA is required
  • Experience preparing pre-IND, IND and BLA documentation is required
  • Track record of success in negotiating with Health Authorities and representing the sponsor to internal and external stakeholders
  • Prior experience leading and managing a regulatory team
  • Track record of successful IND/CTA submissions and approvals/clearance
  • Demonstrated knowledge of drug, biologics and medical device regulation, directives, and regulatory guidance and guidelines. Solid knowledge of GCP, GMP and GLP
  • Experience in leading matrix teams to fulfill regulatory requirements and responsibilities with strong communication
  • Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously
  • Excellent oral and written communication skills

Bayside Solutions

Address

Menlo Park, CA
USA

Industry

Government

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