Manager, Regulatory Affairs Strategy - Oncology

Regeneron; New Jersey; Hybrid; USD 128,600 - 210,000; Full time

Job summary

Regeneron is seeking a Manager in Regulatory Affairs Strategy Oncology to support global regulatory submissions and agency interactions. This role reports to the Global Regulatory Liaison and focuses on clinical and nonclinical development, with on-site work in Tarrytown, NY or Warren, NJ in a hybrid arrangement.

You will coordinate INDs/CTAs and related documents, prepare briefing materials for Agency meetings, and manage responses to inquiries while collaborating with subject matter experts

Qualifications

• Minimum MD, PhD or PharmD with 2+ years regulatory experience.
• Experience filings and preparing regulatory documents.
• Familiarity with US FDA and international pharmaceutical guidance.

Responsibilities

• Coordinate global regulatory submissions (INDs/CTAs, amendments, annual reports, ICB).
• Assist with agency meetings and briefing documents.
• Lead queries and commitments with regulatory authorities and track status.
• Represent study-level regulatory activities in cross-functional teams.

Skills

Regulatory knowledge

Attention to detail

Interpersonal skills

Cross-functional collaboration

Education

MD/PhD/PharmD

Job description

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. 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, NY or Warren, NJ
• Hybrid; 4 days per week on site

Discover Your Role

• Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation
• Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
• Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings

This Role Requires

• Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience.
• We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities.
• If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
• If 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

We are committed to building a workplace with an inclusive culture. 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.

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.

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.

Salary Range (annually)

$128,600.00 - $210,000.00