Associate Manager, Regulatory Affairs Strategy - Oncology
$109,900–$179,300 year
HybridTarrytown, New York, United States or Warren, Michigan, United States
Job Summary
Coordinate global regulatory submissions for oncology therapeutics, including INDs, CTAs, amendments, and orphan drug applications. Manage agency queries, prepare briefing documents for meetings, and track commitments with regulatory bodies. Represent study-level regulatory activities and collaborate on cross-functional product development projects. Maintain current knowledge of US FDA and international guidance to inform regulatory strategy for clinical programs. Exercise independent judgment in managing regulatory affairs across preclinical and clinical development areas.
Required Qualifications
- Minimum Bachelors Degree
- 2-3 years of pharmaceutical industry experience in regulatory affairs
- Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
- High attention to detail
- Ability to organize and prioritize assigned projects according to corporate goals
- Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
- Proficient in written, oral, and interpersonal communications in English
- Work Location: Tarrytown, NY or Warren, NJ Hybrid; 4 days per week 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
Desired Qualifications
- Advanced degree
- experience in oncology
- Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations
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