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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:

• 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.

#LI-Hybrid

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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments 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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

Company: Bristol-Myers Squibb

Req Number: R1582805

Updated: 2024-07-01 04:14:08.958 UTC

Location: Uxbridge-GB

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.