Senior Regulatory Manager ERPS

5 months ago

Uxbridge, United Kingdom Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

The European Regulatory Procedural Strategist (ERPS) team leads and manages the procedural and operational aspects of the European regulatory filings within the European Centralised Procedure, working in close collaboration with the European Regulatory Liaison group and the appropriate regional and global functions.

Key Responsibilities:

Provide EU centralised procedural management expertise & strategies, and lead procedural aspects for new MAA filings and Life Cycle Management (LCM), from (pre-) submissions to approvals, including selection of relevant procedures needed for submission Develop and amend the EU regulatory procedural timelines in alignment with the regulatory strategy and commercial objectives Ensure EU-specific regulatory requirements, including procedural and CMC related, for MAAs and LCM are met Plan and track activities related to regulatory submissions in the EU. Track and inform of regulatory submission dates, regulatory status, nature of changes, minor/significant product information changes within the assigned procedures (planned/ongoing) to all relevant parties. Co-lead communication of procedural milestones. Provide the dossier requirements for each submission and review full dossier for submission. Provide labeling support (competitive label analyses, SmPC and PL preparation, primary responsibility for drafting the PL, readability testing, participate in master mockup creation, etc.) Working together with the European Regulatory Liaison (ERL) in the development process of European regulatory and procedural strategy. Author regulatory documentation in Module 1, prepare/coordinate EU exploratory development documents (e.g. Scientific Advice, paediatric related, orphan), and lead review of quality variations Co-lead a team of regulatory professionals (ERT) with ERL Participate/ Lead reviews of new legislations and guidelines as appropriate, and author/review internal procedures and processes. Represent the group in inter-departmental (global) taskforces. Keep abreast of regulatory requirements and changes, competitive activities, changes in Governmental authorities and requirements to enhance the effectiveness of the function. Participate in development and execution of EU HA engagement plan and any related meetings in connection to the assigned project. Develop, track activities and procedural steps related to EU regulatory submissions, including databases, and inform of regulatory status, nature of changes to all relevant parties

Key Competency Requirements:

Solid scientific background (PhD level desired) At least 3+ years of direct (or relevant) hands-on experience in European centralised procedures(in)direct management experience of major Centrally Authorised projects Great communication, organisation and attention-to-detail skills as well as in depth knowledge of EU Regulatory requirements are clear specificities and a “must” for the job. Good interpersonal skills, strong team spirit and ability to “connect and collaborate” are found essential for this particular job due to the high team collaboration and practice harmonisation expected from this group as well as to the extent of the cross-functional interactions involved in the daily work. Excellent command of spoken and written English, Ability to rapidly adapt to different issues and projects at one time, Good understanding of the pharmaceutical industry and have an understanding of European Regulatory Procedures.

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