Manager, Regulatory Submission Project Management

Location
Tarrytown, NY
Posted
Oct 09, 2019
Ref
16537BR
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary
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).

Requires some guidance from direct manager.

Provides support and backup to management as needed.

Responsibilities
Creates and manages Submission Plans (Table of Contents, timelines, and responsibility matrices)

Coordinates submission documents (routing documents for review, uploading into the EDMS and preparing approvers for upcoming approval tasks) and prepares and manages submission binders

Conducts 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

Negotiates the resolution of submission timeline conflicts with other project managers in preclinical and clinical to align timelines for deliverables feeding into the regulatory timeline

Provides requested submission documents to partners and CROs

Maintains and tracks regulatory commitments and reoccurring submission obligations, such as 6-month distribution reports, annual establishment registration and annual reports

Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance

Assists with regulatory inspection activities

Identifies and communicates regulatory system enhancement needs or technical issues to management and CDRA Systems

Provides guidance on good documentation and submission practices
Requirements

- Bachelor's Degree

- 5 - 7+ Years

Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

Requires eCTD knowledge, and excellent verbal and written communication and presentation skills.

Project management skills strongly desired.

Can work independently, ability to multitask, self-motivated, well organized and adaptable, detail-oriented, able to prioritize and work well with others, 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, Veeva, and SharePoint ) is desirable.

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.