Regulatory Submission Project Management - Specialist
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY
- Start date
- Oct 11, 2019
View more
- Discipline
- Clinical, Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- 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 CTAs and amendments, BLAs, amendments/supplements, MAAs and variations in accordance with applicable regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc.).
Requires some guidance from direct manager.
Provides support and backup to management and other team members as needed.
Responsibilities:
- Creates and maintains submission plans (table of contents, timeline and responsibility matrix), and facilitates the resolution of timeline issues with regulatory and cross-functional team members
- Manages and coordinates submission documents that require reviews and Regulatory Operations processing
- Conducts kickoff, submission core team and line function meetings
- Provides guidance on good documentation and submission practices
- Provides requested submission documents to partners and CROs
- Helps maintain and track regulatory commitments
- Assists with reviewing and developing departmental procedural documents in accordance with applicable regulations and guidance
- Assists with regulatory inspection activities
- Identifies and communicates regulatory system enhancement needs or technical issues to management
Requirements:
- Bachelor's Degree
- 5+ Years
- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc.)
- Requires eCTD knowledge
- Project management skills required
- Working knowledge of pharmaceutical metadata (preferred)
- Can work independently (some guidance from direct manager anticipated), 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 Microsoft Word, Adobe Acrobat, and electronic document management systems are required. Familiarity with Microsoft Project preferred.
- Provides support and backup to management as needed
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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