Director, Regulatory Cmc
vor 5 Monaten
**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.
**Description**
The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.
**Position Summary**
**Position Responsibilities**
- Represent regulatory CMC on and/or lead matrix teams for cell therapy pipeline products and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research
- Independently manage and prioritize multiple complex projects
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
- Identify, communicate and propose resolutions to routine/complex issues
- Interpret global regulations and guidance. Identify regulatory opportunity and risks.
- Anticipate and communicate possible regulatory paradigm shifts
- Participate in product fact finding meetings
- Review and provide regulatory assessments on change controls
- Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
- Mange relationships with diverse teams
- Utilize electronic systems for dossier creation and tracking.
**Requirements**:
- Minimum BA/BS Degree
- Minimum of 10+ years Pharmaceutical industry experience - prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 8+ years CMC regulatory strategy (biologics/cell therapy experience preferred).
- Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological/cell therapy compounds preferred.
- Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the cell therapy drug development process and analytical methods, preferred.
- Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
- Ability to identify, communicate and resolve complex issues.
- Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
- Ability to interpret global regulations and guidance.
- Strong oral and written skills.
- Proficient with electronic systems
**Uniquely Interesting Work, Life-changing Careers**
**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 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.
Bristol Myers Squibb is Disability Confident - Committed
A UK Government scheme
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