Director, Regulatory Affairs Strategy - Oncology

Regeneron Pharmaceuticals, Inc
Lakewood, New Jersey, US
Full-time

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.

Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.

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.

This role might be for you if :

You bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.

You are interacting with CROs in the management of ex-US / ex-EU CTAs towards clinical trial activations preferred.

You have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals.

You bring strong interpersonal skills both written and verbally.

To be considered, you must possess excellent written and verbal communication skills along with a MD, Ph.D. or Pharm D. degree.

We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.

This role requires you to work onsite 3 days per week in either Basking Ridge, NJ, Armonk, NY or Tarrytown, NY.

J-18808-Ljbffr

12 days ago
Related jobs
Promoted
Cornerstone Search Group
NJ, United States

Regulatory Affairs experience, with an emphasis in Oncology and demonstrated experience defining and leading clinical-stage regulatory strategy. DIRECTOR, ONCOLOGY TA GLOBAL REG AFFAIRS STRATEGY LEAD. This hybrid role will lead US and Global regulatory activities in their Oncology therapeutic area, ...

Promoted
Regeneron Pharmaceuticals, Inc
Lakewood, New Jersey

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. Utilize regulatory expertise and knowledge of regula...

Promoted
Sun Pharmaceutical Industries, Inc.
Millstone, New Jersey

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...

Promoted
Regeneron Pharmaceuticals, Inc
Lakewood, New Jersey

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. Utilize regulatory expertise and knowledge of regula...

Promoted
Sun Pharmaceutical Industries, Inc.
Millstone, New Jersey

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...

Promoted
Daiichi Sankyo
Lakewood, New Jersey

The Director, Global Oncology Medical Affairs, Evidence Generation role is responsible for co-leading a cross-functional Evidence Generation Team and developing an Integrated Evidence Plan (IEP) for the assigned compound. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Compet...

Promoted
TANNER & ASSOC INC
Lakewood, New Jersey

Represents Regulatory Affairs on the company’s Promotional Review Committee and provides guidance on current regulatory environment and regulatory considerations that may impact business activities. Associate Director, Regulatory Affairs, Advertising & Promotion—New Jersey. Tanner and Associates...

Promoted
Daiichi Sankyo
Lakewood, New Jersey

Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. This position serves as the GR...

Ferring Pharmaceuticals
New Jersey

As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also ser...

Promoted
Daiichi Sankyo
Lakewood, New Jersey

Leverage disease area strategy or cross-asset strategy by working together with Translational Strategy Leads on other projects, internal and external experts. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovato...