Director, Regulatory Affairs Strategy - Oncology

About the role

The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities.

Responsibilities

• Provide interpretation of regulatory authorities' feedback, policies and guidelines.
• Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports.
• Own the preparation of major clinical submissions required for regulatory approval.
• Work with project teams to resolve complex project issues.
• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
• Ensure quality and timeliness of IND/CTA and BLA submissions.
• Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions.
• Plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas.
• Assure compliance with regulations and with project team timelines.
• Provide interpersonal support and lead personnel.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.

Requirements

• Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred.
• A high attention to detail; ability to coordinate and prioritize assigned projects according to company goals.

Qualifications

• MD, Ph.D. or Pharm D. degree.
• Minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.

Benefits

Includes a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$205,000.00 - $341,600.00 annually

Schedule

This role requires you to work onsite 4 days per week in either Warren, NJ, Tarrytown, NY or Cambridge, MA.