Manager, Regulatory Operations
vor 1 Monat
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: .
The External Manufacturing Quality Organisation is seeking to recruit a Manager, Regulatory Operations who will be responsible for regulatory support activities for Biologics products within External Manufacturing.
Key responsibilities will include, but not limited to:
Act as the Regulatory Operations lead representative for the Boudry-based external manufacturing organization, with responsibility of representing the team in local initiatives and engaging with local leadership.
Working as part of a team dealing with global market registrations and providing regulatory compliance/operations guidance, and support to External Manufacturing teams who have oversight of Contract Manufacturing Organisations.
Maintains strong communication and working relationships with all departments, contract manufacturing organisations, and global personnel such as CMC.
Point of Contact for requests to source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, CoA's, Analytical raw data) to support regulatory requests for post approval variations, renewals, and annual reports.
Support product release by managing appropriate systems to ensure product market compliance to enable seamless release of finished product to the market.
Review of local and global change controls, deviations, CAPA's, technology transfer plans, and regulatory submission plans.
Coordination of EXM quality dossier (Module 2 and 3) review process for Pharmaceutical and Biologics products at all nodes of the supply chain for new product introductions, and post approval variations including but not limited to new manufacturing facilities and process changes.
Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR's, quality risk management).
Qualifications, Knowledge and Skills Required:
The successful candidate will have a minimum of 3 years Quality/Compliance/Technical experience in a biopharmaceutical operations role.
Regulatory experience and familiarity with regulatory dossier sections (Module 2 and 3) would be advantageous.
The candidate should be able to demonstrate:
Ability to work independently and within team matrix environments.
Ability to manage teams associated with individual aspects of responsibilities, direct people management and project management aspects.
Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements.
In depth knowledge of Quality Management Systems with an emphasis on change control principles and the applicability of restriction/regulatory holds in the release process for changes that require health authority approval.
Ability to assess the right balance between the business implications, technical considerations and quality decisions.
Excellent organisational and administration skills are required in addition to strong interpersonal skills.
The successful candidate must be able to prioritise, organise and manage multiple tasks to tight deadlines.
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 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 . Visit 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.
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