Manager, Regulatory Affairs coordinating global regulatory submissions for therapeutic development. Collaborating cross - functionally to meet regulatory agency requirements and ensure compliance.
About the role
- Director of Regulatory Affairs responsible for regulatory strategies in diagnostics and medical devices. Collaborating with teams to align testing with therapeutic development in a clinical setting.
Responsibilities
- Develop European and/or UK regulatory strategy for the designated program
- Contribute to clinical development plans to align diagnostic testing
- Act as representative of European regulatory team at global regulatory team for designated projects
- Drive strategy and oversee Dx/CDx and Device related content of regulatory documents
- Provide submission gap analyses, identify potential risks and propose solutions
- Oversee Dx/CDx and Device related regulatory agency communications, submissions, and approvals
- Lead and mentor team members
- Maintain up-to-date knowledge of laws, regulations, and guidelines across European regulatory authorities
Requirements
- Minimum of 10+ years’ experience in the biotechnical or pharmaceutical industry with a bachelor's degree
- Minimum of 10 years’ experience in a Regulatory capacity with increasing responsibility
- Seasoned negotiator with a solid background in medical devices/diagnostic development regulations
- Experience working with Notified Bodies and various Member State HAs
- Sound understanding of the drug and diagnostic development process
- Recent experience with diagnostic testing to support clinical trials in all phases of study
- Proven ability to deliver on goals in a cross-functional environment
- English native speaker preferred
Benefits
- Equal opportunity employer
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Scientist responsible for developing and maintaining Core Labeling for pharmaceutical products. Collaborating with global teams to ensure compliance with regulatory requirements and quality standards.
Compliance Intern offering forensic analysis support for Johnson & Johnson. Engaging in audits and analytical tasks in a hybrid work environment in New Brunswick, NJ.
Director, Global Regulatory Leader responsible for global regulatory strategies in innovative medicine for investigational products. Leading cross - functional teams and ensuring regulatory compliance with health authorities.
GRC Analyst supporting Siteimprove's security governance, risk, and compliance team. Engaging with customers, managing vendor security reviews, and enhancing security practices.
Compliance Manager overseeing United Rotorcraft’s compliance initiatives with federal standards. Ensuring audit readiness and managing supplier compliance and training programs.
Regulatory Compliance Projects Manager at Betclic ensuring compliance in product development and coordinating regulatory matters across jurisdictions. Leading cross - functional projects in a dynamic environment.
Trade Compliance Officer managing US trade compliance operations for Thales' InFlight Entertainment Business Line. Developing and implementing comprehensive trade compliance programs aligned with regulatory requirements.
Quality & Compliance System Senior Specialist overseeing Quality Management Systems in a global biopharmaceutical company. Ensuring GMP compliance and continuous improvement in quality processes.
Covenant Compliance Review Analyst responsible for monitoring covenant compliance tests and financial statements. Supporting Relationship Managers with compliance and documentation for commercial clients.