Bristol Work From Home Jobs Advisor Full Time
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Industry: Private
Employment Type: Full Time
Work Hours: 8
Salary: £35 – £45Hour
Location: United Kingdom
Company: Bristol-Myers Squibb
Description:
Bristol Work From Home Jobs Advisor Full Time
he CMC Regulatory Director, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions. In this role, the GRS-CMC Director, Cell Therapy will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) & Cell Therapy Development Operations (CTDO). The GRS-CMC Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
Bristol Work From Home Jobs Advisor Full Time
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 provide strategic guidance/input related to current regulatory requirements and expectation for biologics/cell therapy marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
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.
Bristol Work From Home Jobs Advisor Full Time
Requirements
Minimum BA/BS Degree
Minimum of 6+ 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
Bristol Work From Home Jobs Advisor Full Time
About the Bristol-Myers Squibb Company :
Bristol-Myers Squibb (BMS) is a prominent global biopharmaceutical company with operations in the United Kingdom. Known for its innovative approach to pharmaceuticals, BMS focuses on the discovery, development, and delivery of transformative medicines for patients with serious diseases. Their research spans several therapeutic areas, including oncology, immunology, cardiovascular disease, and fibrosis.
In the UK, Bristol-Myers Squibb operates through various facilities and partnerships. The company’s presence in the UK is significant, with a focus on research and development (R&D), clinical trials, and collaborations with local healthcare institutions and universities. The UK operations support BMS’s global mission to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.
Bristol-Myers Squibb’s UK headquarters is located in Uxbridge, West London. This site serves as a hub for their commercial and administrative functions. Additionally, the UK team plays a crucial role in conducting clinical trials, which are essential for the development of new therapies. These trials often involve collaborations with the National Health Service (NHS) and various academic institutions, ensuring that the UK remains at the forefront of medical research and innovation.
The company is committed to contributing to the local community and healthcare landscape in the UK. This includes initiatives aimed at improving patient outcomes, enhancing access to medicines, and supporting health-related education and awareness programs. BMS UK also engages in various corporate social responsibility activities, emphasizing sustainability and ethical business practices.
Overall, Bristol-Myers Squibb in the United Kingdom exemplifies the company’s global commitment to innovation, collaboration, and patient-centric care, striving to make a meaningful impact on health and well-being.
Bristol Work From Home Jobs Advisor Full Time
Bristol Work From Home Jobs Advisor Full Time In RealJobs
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