Associate Manager, Regulatory Affairs Strategy - Oncology

About the role

We are seeking an Associate Manager to join our Regulatory Affairs Strategy (Oncology) team. This role reports to the Global Regulatory Liaison (GRL) and provides support in all aspects of regulatory affairs related to the development of novel therapeutics, including quality, preclinical, and clinical areas of drug development, as well as the policies and 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.

Work locations: Tarrytown, NY or Warren, NJ (4 days per week on site).

Responsibilities

• Coordinate the preparation, submission, management, and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in the oncology therapeutic area, including 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.
• Manage and track queries and commitments with regulatory agencies; collaborate with subject matter experts to provide written responses to queries and provide 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.
• Perform research to support the development of regulatory strategy for the assigned clinical development program.
• Maintain knowledge of regulatory requirements up to current date, comment on draft regulatory guidance, and communicate changes in regulatory information as needed.
• Exercise discretion and independent judgment in the performance of the duties described above.

Requirements

• Minimum MD, PhD, or PharmD degree along with relevant internship, fellowship, post-doc experience, or industry experience.
• Experience in oncology preferred.
• Knowledgeable 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.
• High attention to detail; ability to organize and prioritize assigned projects according to corporate goals.
• Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization.
• Proficient in written, oral, and interpersonal communications in English.

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., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Pay

Salary Range (annually): $109,900.00 - $179,300.00 (for jobs in Canada). 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.