Senior Manager - Regulatory Info Management (RIM) - 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 ensuring RIM data standards processes and management in regulatory systems in lieu of supporting submission archiving activities 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 minimal guidance from direct manager.
Functions as a contributor as needed.
Provides support and backup to management as needed.
- Develop, monitor and enforce data/record management policies, procedures, and standards.
- Participate in change initiatives to ensure that the introduction of undesirable impacts to data definition, maintenance, quality and/or consumption are minimized
- Ensure regulatory data is compliant with defined standards, policies and quality requirements
- Responsible for overseeing regulatory information quality, reporting and analytics to monitor quality and maximize the use of regulatory information.
- Support in development of RIM focused data definitions, business rules and standards for Regulatory Information Management
- Archives (categorizing and classifying information) all Regulatory records pertaining to multiple Regulatory Applications (INDs, BLAs, etc.), maintaining Regulatory application indexes, tracking of regulatory documents, and assisting with special projects as needed.
- Manage and maintains all electronic and paper archives for all Regulatory submissions, submission documents, and any related correspondence for multiple Regulatory Applications (INDs, BLAs, etc.)
- Provide a guidance, maintains and ensures Regulatory information is accurate in Regulatory systems
- Provide leadership and subject matter expertise in managing regulatory information data with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance
- Assists with audit and inspection activities including retrieval of Regulatory information
- Participates in Regulatory Systems projects by assisting with system validation activities that support RIM processes
- Provide the leadership and subject matter expertise in archiving projects such as migrating previously scanned paper submissions, legacy documents, and archive index information into the Regulatory EDMS
- Assists with user training
- Assists with managing paper archives
- Assists with managing RIM knowledge objects
- Identifies and communicates regulatory system enhancement needs or technical issues
- Highschool (15 + years)
- Associate's Degree (10 - 12 + years)
- Bachelor's Degree (7 - 10 + years)
- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc) and drug development process
- Experience in Regulatory Operations
- Thorough knowledge and practical experience in global submissions and principles of information systems.
- Knowledge of scientific industry terminology and how to effectively use as metadata.
- Strong knowlage of categorization and classifying information.
- Expert knowledge of relationships between key components of Regulatory 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 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 and manage time well, works effectively under pressure, has strong critical thinking skills, and has excellent written and verbal communication skills.
- Working knowledge of RIM solutions, electronic document management systems (Veeva Vault preferred), eCTD publishing systems (eCTD Manager preferred), eCTD validation and viewing tools, XML, 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
- Will 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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