Manager, Regulatory Information Management

Location
Tarrytown, NY, United States
Posted
Sep 04, 2019
Ref
16831BR
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 managing and archiving of Clinical Trial (CT) application regulatory submissions and related deliverables.
Requires minimum guidance from direct manager.
Functions as a contributor as needed.
Provides support and backup to management as needed.

Job Duties:

Responsible for coordination, monitoring, and tracking Clinical Trial (CT) country regulatory submission deliverables including health authority correspondences and approval letters.

Assure the proper management, retention, and version control of all applicable clinical trial application (CTA) submissions to regulatory health authority.

Manage and oversee CTA regulatory submission/document transfers between Regeneron and CROs.

Interact with Regulatory Affairs personnel, IOPS CMC/QA team, and Regulatory Submission Project Management team to define submission deliverables (e.g. Protocol, IMPD-Quality); Coordination and collaboration with other global teams/functions (EU regions) to support local and global regulatory needs.

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.
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
3-5 Year's 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 required.

Experience in Regulatory Affairs/Operations/information.

Effective planning, organizational and interpersonal skills.

Thorough knowledge and practical experience with RIM technologies

Knowledge of scientific industry terminology

Strong knowledge of categorization and classifying information

Ability to lead, manage, and/or contribute to multiple ongoing projects simultaneously

Ability to lead, manage, and/or contribute to improvement initiatives

Strong knowledge of technical writing is required

Project management experience preferred

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, XML, Microsoft Office suite, and Adobe Acrobat are required. Working knowledge of technical writing is preferred.
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills
May be responsible for supervising staff.

7 - 10 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.