Associate Manager, Regulatory Information Management - Process Systems

Employment Type

: Full-Time

Industry

: Non-Executive Management



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Summary: 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. Job 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 Collaborates with the Regulatory Systems team and key stakeholders 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 data steward(s) with implementing data standards to facilitate data quality within RIM systems Function as a super-user and RIM expert on all system-supported processes and data requirements. 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 Strong knowledge of relationships between key components of Regulatory Information Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.) Ability to manage, and/or contribute to multiple ongoing projects simultaneously Ability to 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 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 8-10 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.Salary Range: NAMinimum Qualification8 - 10 years

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