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Senior Regulatory Manager
View: 172
Update day: 29-03-2024
Location: Boudry Neuchâtel NE
Category: Legal / Contracts
Industry: Pharmaceutical Manufacturing
Position: Mid-Senior level
Job type: Full-time
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Job content
Working with UsChallenging. 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.
- 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.
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Deadline: 13-05-2024
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