Senior Manager, Regulatory Submission Project Management
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Responsible for leading and managing Regulatory submission deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Require minimal guidance from direct manager.
Provide support and backup to management as needed.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
Work with cross-functional teams to develop submission plans (table of contents, timelines, and responsibility matrices) for original IND applications, major IND amendments, and marketing applications.
Conduct kickoff and other cross-functional meetings related to submissions, such as IND working group meetings related to briefing books, IND responsibilities review, IB kickoff, document review resolution discussions
Present submission timeline plan at IND/BLA meetings
Facilitate meetings to discuss timeline mitigation plans for delayed activities
Coordinate submission documents (routing documents for review, uploading into the EDMS and preparing approvers for upcoming approval tasks) and prepare and manage submission binders
Provide requested submission documents to partners and CROs
Assist with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance
Assist with regulatory inspection activities
Assist with identifying and communicating regulatory system enhancement needs or technical issues to management and CDRA Systems
Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
eCTD knowledge and project management skills preferred.
Can work independently, ability to multitask, self-motivated, well organized and adaptable, detail-oriented, able to prioritize, work well with others, work effectively under pressure, and has excellent written and verbal communication skills.
Working knowledge with MS Office applications and Adobe Acrobat is required. Working knowledge of MS Project and electronic document management systems (eg, Veeva, and SharePoint ) is desirable.
May be responsible for supervising staff.
Minimum Years of Experience: Please be as specific as possible
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.