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Senior Regulatory manager

3 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.

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. Read more: careers.bms.com/working-with-us

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:

  • Manages the operational and procedural aspects and provide support for new Marketing Authorisation Applications' preparation and filings and also Life Cycle Management for the European Centralised Procedures .
  • Plan and track activities related to regulatory submissions in the EU.
  • Systematic communicator of regulatory submission dates, regulatory status, nature of changes, track and inform of minor/significant product information changes to all relevant parties.
  • Provide labeling support (competitive label analyses, SmPC and PL preparation, primary responsibility for drafting the PL, readability testing, participate in master mockup creation, etc.)
  • Provide logistic support for meetings with EMA and national Health Authorities and any other related meetings in connection to the assigned project.
  • Working together with the European Regulatory Liaison (ERL) in the development process of European strategy through research (competitors, guidelines...) and membership of multidisciplinary Project Teams (including with business), as necessary.
  • Author regulatory documentation in Module 1, and lead review of quality variations.
  • Back-up ERL as needed, in teams and with Health Authorities.
  • Lead reviews of new legislations and guidelines as appropriate, and author/review internal procedures and processes. Represent the group in inter-departmental (global) taskforces.
  • Develop and ensure maintenance planning, tracking/monitoring of processes
  • Keep abreast of regulatory requirements and changes, competitive activities, changes in Governmental authorities and requirements to enhance the effectiveness of the function.

Key Competency Requirements:

  • Solid scientific background (PhD level desired)

  • At least 3+ 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.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science⢠", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb is Disability Confident - Committed

A UK Government scheme