Manager, Regulatory Affairs Strategy - Oncology
About The Position
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/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.
Requirements
- Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience.
- Individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities.
- Good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
- Strong interpersonal skills both written and verbally
Nice To Haves
- Interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
Responsibilities
- 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, the following: 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
- Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
