Director, Regulatory Affairs Strategy - Oncology

Regeneron Pharmaceuticals • Warren, MA

2d • Hybrid

About The Position

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. In this role, a typical day might include the following: 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. Responsible for 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. Successfully 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

• MD, Ph.D. or Pharm D. degree.
• Minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
• Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• High attention to detail; ability to coordinate and prioritize assigned projects according to company goals.
• Excellent written and verbal communication skills.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.

Nice To Haves

• Interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred.

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.
• Responsible for 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.
• Successfully 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.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree