Manager, Regulatory Affairs Strategy - Oncology
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.When & where:Work Location: Tarrytown, NY or Warren, NJ4 days per week on siteDiscover your 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, 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 This role requires:Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience.We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities. If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals You bring strong interpersonal skills both written and verbally Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership o...