Associate Director, Regulatory Information Management

Location
Tarrytown, New York, US
Posted
Sep 13, 2018
Ref
14073BR
Required Education
Bachelors Degree
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.

Duties:

Accountable for leading, developing, and mentoring the RIM team in a global capacity, which includes overseeing managers and staff who are responsible for project managing business systems projects; creating, maintaining, and training on pertinent Regulatory procedural documents; supporting business needs by liaising with internal stakeholders, the Regulatory Systems team, IT, and vendors to identify technical solutions; development and training on Regulatory submission document templates; training on Regulatory Information Management (RIM) systems and tools; archiving Regulatory records pertaining to multiple Regulatory Applications such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations all in accordance with applicable Regulatory Agency regulations, guidance, and/or specifications (eg, FDA, EMA, ICH, etc); marketing Regulatory systems and tools across the organization; and managing all Regulatory information pertaining to these applications.

Works with minimal to no guidance and demonstrates strategic thinking.

Functions as a contributor as needed.

Provides support and backup to management as needed.

Ensures development, implementation, and maintenance of applicable procedure documents in support of business requirements and in accordance with all applicable Regulatory regulations, guidance, and specifications

Oversees a team who develops business cases for desired technology and process improvements (in collaboration with stakeholders)
Ensures training is provided for applicable RIM processes, Regulatory document templates, and Regulatory systems Develops and implements strategies to ensure effective utilization of RIM system capabilities
Identifies regulatory system enhancement needs or technical issues and works closely with systems, technical support staff, and vendors to identify, develop, and implement solutions
Oversees and drives system improvement projects, ensuring appropriate collaboration with stakeholders
Drive development of test scripts and validation of systems that support RIM processes
Develops, implements, and manages Regulatory Information Governance
Develops capabilities to assist RIM system consumers with identifying key information relationships using pertinent metadata
Communicate key RIM-related information to consumers, and collect and act on feedback
Proactively monitor and provide insight into new Regulatory requirements, guidance, and/or specifications relevant to RIM
Collaborate with key stakeholders on the development of an MDM (Master Data Management) solution
Collaborate with stakeholders on the initiation and deployment of an IDMP solution for data collection, data maintenance, and data reporting
Proactively research industry and technology trends that could impact current systems and processes
Ensures staff is preparad to assist with audit and regulatory inspection activities
Analyzes resource needs and secures additional resources as needed
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Requirements:

Bachelor's Degree (preferred)
15+ 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.