Specialist, Regulatory Information Management
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY
- Start date
- Oct 4, 2019
View more
- Discipline
- Information Technology, Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Summary:
Responsible for tracking and archiving of Clinical Trial (CT) application regulatory submissions and related deliverables.
Requires some guidance from direct manager.
Functions as a contributor as needed.
Provides support and backup to management as needed.
Job Duties:
Responsible for tracking Clinical Trial (CT) country regulatory submission deliverables including health authority correspondences and approval letters.
Manage and oversee CTA regulatory submission/document transfers between Regeneron and CROs.
Collect, upload and manage all Regulatory Agency communications, in all formats (e.g. emails, Phone conversations, hard copy letters, etc.) within Veeva Vault RIM document repository. Similarly manage Partner submission exchange.
Archives (categorizing and classifying information) all Regulatory records pertaining to Regulatory Applications (CTA), maintaining Regulatory application indexes, tracking of regulatory documents, and assisting with special projects as needed.
Supports development of procedure documents, or best practices for RIM
Collaborates with the functional area team and key stakeholders
Communicates key RIM-related information to consumers, collects feedback, and takes action
Assists with audit and inspection activities including retrieval of Regulatory information
Assists RIM Training team with developing RIM-specific training on how to effectively access Regulatory information
Assists data steward(s) with implementing data standards to facilitate data quality within RIM systems
Requirements:
Bachelor's Degree
1 -2 years experience
Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).
Knowledge and practical experience in managing global Clinical Trial Applications (e.g. IMPD)
Knowledge of pharmaceutical drug and device development process.
Project management experience preferred.
Effective planning, organizational and interpersonal skills.
Experience in Regulatory Affairs/Operations/information.
Thorough knowledge and practical experience with RIM technologies
Knowledge of scientific industry terminology
Strong knowledge of categorization and classifying information
Ability to manage, and/or contribute to multiple ongoing projects simultaneously
Ability to manage, and/or contribute to improvement initiatives
Strong knowledge of technical writing is required
Ability to engage and influence a variety of stakeholders at all organizational levels required
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.
Working knowledge of RIM technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, Microsoft Office suite, and Adobe Acrobat are required.
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills
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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