Manager, Regulatory Affairs Strategy - Oncology

Discover Your Role
- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical product development, 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 documents.
- Lead and track queries and commitments with regulatory agencies; collaborate with subject matter experts to provide written responses; provide periodic status updates.
- 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 with 2+ years of regulatory experience.
- Experience working on filings, developing regulatory 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.
- Interaction with CROs managing ex-US/ex-EU CTAs toward clinical trial activations (preferred).
- High attention to detail; ability to coordinate and prioritize assigned projects.
- Strong interpersonal skills, both written and verbal.

When & Where
- Work location: Tarrytown, NY or Warren, NJ.
- 4 days per week on site.

Application instructions
- Apply now.