Manager Regulatory Information Management- Business Analysis

Location
Tarrytown, New York, US
Posted
Aug 12, 2018
Ref
13411BR
Required Education
Other
Position Type
Full time
Position Summary

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 supporting the business processes and regulatory systems to support submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Requires some guidance from direct manager.
Functions as a contributor as needed.
Provides support and backup to management as needed.

Duties:

Supports development of procedure documents, or best practices for RIM

Provides business support for all new and existing RIM technology

Supports system validation activities by developing and executing test scripts for systems that support RIM processes

Assists with identifying RIM related user requirements and use cases (in collaboration with cross-functional stakeholders)

Provides subject matter expertise on RIM related projects

Liaises with system and service vendors

Collaborates with the Regulatory Systems team and key stakeholders

Assists with developing RFIs and/or RFPs for RIM system projects

Assists with RIM technology solution identification

Assists with monitoring and tracking new functionality (inclusive of enhancement requests) with each new release of RIM technology solutions

Communicates key RIM-related information to consumers, collects feedback, and takes action

Assists with analyzing new RIM technology features and assists with deployment in collaboration with the Regulatory Systems team

Assists with providing insight into new regulations, requirements, guidance, and/or specifications relevant to RIM technology

Assists with developing, implementing, and managing Regulatory Information Governance

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

May be responsible for supervising staff in addition to implementing employee development plans.

Requirements:

Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).

Knowledge of pharmaceutical drug and device development process.

Experience in Regulatory Affairs/Operations/information.

Thorough knowledge and practical experience in global submissions

Thorough knowledge and practical experience with RIM technologies

Knowledge of scientific industry terminology

Strong knowledge of categorization and classifying information

Expert knowledge of relationships between key components of Regulatory Information

Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.)

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

Training or public speaking experience preferred

Change management experience preferred

knowledge of SDLC methodologies preferred

Strong knowledge of 21 CFR Part and Annex 11 Regulations

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.

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.