Manager, Regulatory Affairs Strategy - Oncology

About the 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:

• INDs/CTAs, amendments and information requests
• Orphan drug applications
• Annual Reports and Investigators 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, and 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.

Requirements

• Minimum MD, PhD, or PharmD degree along with 2+ years of regulatory experience
• Experience with filings, developing regulatory-related documents, and engaging with external partners and authorities
• Good understanding 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 coordinate and prioritize assigned projects according to company goals
• Strong interpersonal skills, both written and verbal

Work Location

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

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
• Family support benefits

For additional information about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, additional information will be provided during the recruitment process.

Pay

Salary Range (annually): $128,600.00 - $210,000.00 (for jobs in Canada, this posting is for an existing position).