DIRECTOR REGULATORY CMC

We are a recruiting company EasyHiring looking for candidates for the position of Director Regulatory CMC in Bolton, MA for our partners.

Job Description

Director, Global Regulatory Sciences - CMC - Cell Therapy

Division

Research and Development / Global Regulatory, Safety and Biometrics / Global Regulatory Sciences - Chemistry Manufacturing and Controls (GRS-CMC)

Functional Area 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 / Objective

The 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.

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.

Degree Requirements

Minimum BA/BS Degree

Experience Requirements

• 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.

Job Type: Full-time

Experience level:

• 10 years
• 11 years

Work Location: On the road