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Regeneron Pharmaceuticals
,
London, Greater London
Senior Manager, Regulatory Publishing & Planning
Overview
Job Description
Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged. Summary: This newly formed position comprises Regulatory Submission Project Management as well as Regulatory Publishing. The Senior Manager, Regulatory Publishing and Planning - EU/ROW, manages the process and execution of submissions, including overseeing document approvals as well as publishing in electronic format using various technical publishing tools. In addition, this person will manage direct reports, vendors, and serve as a resource internally on regulatory systems for EU/ROW. Responsibilities: Electronically formats and publishes electronic documents and builds Regulatory submission deliverables while ensuring quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures. Manages staff who electronically format and publish electronic documents and build Regulatory submission deliverables. Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g. FDA, EMA, ICH, etc.) as well as good documentation and submission practices For EU/ROW Submissions - coordinates submission documents through review cycles and provides guidance to cross-functional groups on uploading submission documents to the regulatory submission document management system For EU/ROW Submissions - Manages overall completeness of scheduled submissions Provides and retrieves requested submission documents to and from partners and CROs Identifies Regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions Assists with Regulatory inspection activities regarding submission-related inquiries Maintains Authoring Template Library and works with cross-functional teams to develop and maintain templates Collaborates with vendors who support Regulatory operations related tasks. Works with colleagues on upcoming IDMP activities, as well as further development of RIM-related systems from an EU/ROW capacity. Requirements: Bachelor's degree required Minimum of 10+ years in Regulatory Operations Planning/Submissions Publishing Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g. FDA, EMA, ICH, etc.) Working knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required. Works independently at the most advanced level across multiple areas Demonstrates exceptional initiative, creativity and innovation skills Applies advanced in-depth and broad knowledge and considered top "go-to" resource in their field Makes decisions on complex to highly complex issues regarding work approach for project components and completion of team tasks and responsibilities 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 Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media. We do not interview candidates on Google Hangouts. Any questions about job listings can be directed to candidatesupport@regeneron.com. We also do not hire for "at-home data entry" positions.