Manager, Regulatory Affairs Strategy - Oncology

Job Summary

The Manager, Regulatory Affairs will coordinate global regulatory submissions and assist in coordination and preparation for agency meetings. They will also lead and track queries and commitments with regulatory agencies, collaborate with subject matter experts, and represent study-level regulatory activities.

Responsibilities

• Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development.
• Aid in coordination and preparation for Agency meetings and associated briefing document preparation.
• Lead 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.
• Represent for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings.

Requirements

• MD, PhD or PharmD degree with 2+ years of regulatory experience.
• Experience working on filings, developing regulatory related documents, and engaging with external partners and authorities.
• Understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience managing CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred.
• High attention to detail and ability to coordinate and prioritize assigned projects according to company goals.
• Strong interpersonal skills both written and verbally.

Qualifications

• Minimum MD, PhD or PharmD degree.
• 2+ years of regulatory experience.
• Experience with US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience working on filings, developing regulatory related documents, and engaging with external partners and authorities.
• Experience managing CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred.
• High attention to detail and ability to coordinate and prioritize assigned projects according to company goals.
• Strong interpersonal skills both written and verbally.

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 here.

Pay

$128,600.00 - $210,000.00 annually

Schedule

Hybrid; 4 days per week on site