Sr. Manager, Regulatory Information Management (Process and Systems) - Tarrytown
Employment Type: Full-Time
Industry: Non-Executive Management
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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.
Responsible for supporting the business 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.
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
Assist 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
Analyzes 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.
BS, MS or Advanced degree in a scientific discipline
At least 8 years experience
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
Experience in SOP writing is preferred
Change management experience preferred
Knowledge of SDLC methodologies preferred
Knowledge of 21 CFR Part and Annex 11 Regulations is 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 skill
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.
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