Senior Regulatory Manager, ERPS - Switzerland Hybrid ( 50% remote/50% on-site) (m/f/d)

Bristol Myers Squibb

Boudry
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  • Publication date:

    30 September 2022
  • Workload:

    100%
  • Contract:

    Permanent position

Senior Regulatory Manager, ERPS - Switzerland Hybrid ( 50% remote/50% on-site) (m/f/d)

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.?In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Role

Bristol Myers Squibb is looking to recruit a permanent Senior Regulatory Manager, European Regulatory Procedures Strategy (ERPS), based in Boudry, Switzerland.

Position Summary

Pre??and post?authorisation management and strategy of EU regulatory procedural and related operational activities, as a procedure strategist for Centrally Approved Products for compliant dossier content and timely submission and approval.

Key Duties and Responsibilities:

  • Provide EU procedural management expertise & strategies, and lead procedural aspects for new MAA filings and Life Cycle Management (LCM), from (pre?) submissions to approvals.
  • Ensure EU?specific regulatory requirements, including procedural and CMC aspects, for MAAs and LCM are met.
  • Develop, plan and track activities and procedural steps 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.
  • Develop, amend, as needed, and communicate the EU regulatory procedural timelines and status, aligned with regulatory strategy and commercial objectives.
  • Co?lead communication of procedural milestones.
  • Provide the dossier requirements for each submission, and review full dossier for submission.
  • 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.
  • Provide labeling input and support (competitive label analyses, SmPC and PL preparation, primary responsibility for drafting the PL, readability testing, participate in master mockup creation, etc...).
  • Participate in development and execution of national HA/EMA meetings and any related meetings in connection to the assigned project.??
  • Support European Regulatory Liaison (ERL) in the development process and execution of European strategy through research (competitors, guidelines...) and membership of multidisciplinary Project Teams (including with business), as necessary.
  • Back?up ERL as needed, in teams and with Health Authorities.
  • Keep abreast of EC/EMA procedural guidelines, HA requirements and EU templates, and adapt to the company's need & strategy.
  • Monitor, assess & timely inform the teams about any regulatory competitive information, including timelines scenarios and supportive guidelines.
  • Lead/participate in reviews of new EU legislations and guidelines as appropriate, and author/review internal procedures and processes. Represent the group in inter?departmental (global) taskforces.
  • Lead a team of regulatory professionals with ERL and senior management.

Qualifications, Knowledge and Skills Required:

  • Solid scientific background (PhD level desired)
  • At least 3-5 years of direct (or relevant) hands-on experience in European regulatory procedures
  • (in)direct management experience of? major projects, leadership skills
  • Work on LCM and MAA with minimum supervision, support early projects, take leadership role for non-project based support. Take initiative to support and serve as backup for other ERPM as needed
  • Represent the department in Global task forces, develop processes inter and intra dept.
  • Take part of the training and integration of new members
  • 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.

Why you should apply

  • You will help patients in their fight against serious diseases
  • You will?be part of?a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You'll get a competitive salary and a great benefits package
  • Bristol Myers Squibb has been certified as a Great Place to Work in Switzerland! Each day, our collaborative teams come together to support some of the most interesting work of their careers.

For more information about Bristol Myers Squibb, visit us at https://careers.bms.com

#LI-Hybrid

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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  • Bristol Myers Squibb

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