Associate 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 project management of 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).
May manage Regulatory Coordination staff. Requires some guidance from direct manager. Provides support and backup to management as needed.
Essential Functions required for the job. List both technical and managerial requirements if applicable. Creates and maintains Submission Plans (Table of Contents, Timeline, and responsibility matrix)
Coordinates submission documents (routing documents for review and uploading into the
Conducts kickoff, submission core team, and line function meetings Provides guidance on good documentation and submission practices Facilitates the resolution of timeline issues
Provides requested submission documents to partners and CROs
Maintains and tracks regulatory commitments
Assists with reviewing and developing departmental procedural documents in accordance with
Agency regulations and guidance
Prepares and submits CAS and USAN applications
Assists with regulatory inspection activities
Analyzes resource needs and communicates the need for additional resources to management as needed.
Ensures regulatory system enhancement needs or technical issues are identified and solutions implemented in collaboration with CDRA Systems
Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Requires eCTD knowledge.
Project management skills desired.
Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
Strong knowledge with MS Office applications and Adobe Acrobat is required. Strong knowledge with MS Project and electronic document management systems (eg, SharePoint) is desirable.
May be responsible for supervising staff.
8-10 Years of Experience
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.
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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.