BioSpace
Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
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As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions.
Where And When
This is an Uxbridge based position and would require you to be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. If eligible, we can offer relocation benefits.
Discover Your Role
- Lead product development activities from a CMC regulatory standpoint with input from senior management.
- Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities.
- Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.
- Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
- Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
- Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents.
- Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks.
- Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.
- Identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency.
- Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
- Find opportunities to initiate operational changes and policy modifications. Manage and coach team member(s).
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This Role Requires
- To be considered a bachelors degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience. An advanced degree is preferred.
- Proven track record supporting biological products through development and approval is a distinct advantage.
- It is required to have a good understanding of current CMC worldwide regulations and guidelines.
- Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products is a plus.
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 of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
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Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
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. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
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