Temporary - Associate Manager, Regulatory Project Management

Regeneron; New Jersey; On-site; USD 120,000 - 160,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Temporary Associate Manager to join Regulatory Project Management. The role leads strategic planning and execution of regulatory milestones from IPA to post-marketing, with potential as the lead for a therapeutic area.

On-site work at multiple locations is required. The position requires 5+ years of industry experience and strong regulatory knowledge of FDA, EMA, ICH guidelines.

Qualifications

• 5+ years of industry and/or relevant experience.
• Strong knowledge of FDA, EMA, ICH regulations and guidelines.
• Working knowledge of MS Office applications and Adobe Acrobat; SharePoint desirable.

Responsibilities

• Lead strategic planning and execution of regulatory milestones from IPA to post-marketing.
• May serve as Reg PM lead for assigned therapeutic area and ensure success of regulatory programs.
• Coordinate regulatory timelines, submission plans, and cross-functional milestones.
• Chair or facilitate regulatory sub-team meetings and kickoff meetings for major submissions.
• Communicate program projections and progress to cross-functional teams and upper management.

Skills

Regulatory project management

Cross-functional leadership

Regulatory submissions

MS Office

Adobe Acrobat

SharePoint

Tools

MS Office

Adobe Acrobat

SharePoint

Job description

Temporary - Associate Manager, Regulatory Project Management

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Temporary - Associate Manager to join our Regulatory Project Management team. This role is responsible for leading strategic planning and execution of regulatory milestones from IND Project Approval (IPA) to post-marketing. May serve as the Reg PM lead for assigned therapeutic area (TA) and ensure success for regulatory programs under that TA.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Tarrytown, Warren, or Cambridge
• 3- 4 days per week on site

Discover your role:

• Partners with Regulatory Affairs in driving program team to successfully meet regulatory milestones
• Facilitates Global Regulatory Sub-team meetings with Regulatory Affairs liaison as the meeting chair
• Conducts working group meetings to monitor and track progress of major submissions
• Conducts kickoff meetings for major submissions, including those for INDs, CTAs, BLAs, sBLAs and MAAs and variations
• Reviews regulatory portfolio slides for complete and accurate milestones dates to help prepare for cross-functional and upper-management discussions
• Creates submission timelines and responsibility matrices through cross-functional discussions
• Maintains accurate program timelines for cross-reporting with other functional groups
• Communicates program projections and progress and serves as the key contact for coordinating regulatory activities and milestones
• Provides guidance to team members and cross-functional groups to resolve issues related to timelines, submission documents or other regulatory-related matters that could impact the timeliness or quality of submissions
• May provide oversight of therapeutic area(s) by guiding other team members who are responsible for project managing regulatory milestones such as pre-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, and BLA annual reports

This role requires:

• 5+ years of industry and/or relevant experience
• Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
• Working knowledge with MS Office applications and Adobe Acrobat is required. Working knowledge of electronic document management systems (eg, SharePoint) is desirable.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

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