Regulatory Submission Project Management Specialist
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY, United States
- Start date
- Jun 28, 2019
View more
- Discipline
- Clinical, Clinical Medicine, Clinical Project Management
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Job Duties:
Essential Functions required for the job. List both technical and managerial requirements if applicable.
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:
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.
5-7 years
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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