Manager, Regulatory Operations

vor 5 Monaten

Boudry, Schweiz Bristol-Myers Squibb Vollzeit

**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.

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**:
Regulatory experience and familiarity with regulatory dossier sections (Module 2 and 3) would be advantageous.

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.

**Uniquely Interesting Work, Life-changing Careers**

**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 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.

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