Director, Regulatory Affairs

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Those who join our client as employees feel a sense of ownership about their future.

You will excel in an environment characterized by respect, innovation, and growth opportunities.

Here, you will join passionate professionals who advance their scientific, technical, and professional skills to develop products designed to protect life.

Reporting to the Device Regulatory Affairs Lead, the Director of Regulatory Affairs will oversee and establish the regulatory activities and strategies for the Company's device product portfolio.

The Director, Regulatory Affairs (RA) is responsible for leading the development and implementation of RA strategies for the device franchise and for establishing optimal regulatory positions for new and existing commercial products.

Job Summary The Director, Regulatory Affairs will oversee regulatory activities across our product portfolio.

This role involves providing strategic direction related to EU & global licensure of company products, leading the development and implementation of RA strategies, and maintaining licenses for existing products.

Key Responsibilities Direct and develop the regulatory team across multiple sites or remotely.

Develop and lead regulatory strategies for the EU and global markets for all products.

Provide regulatory guidance to cross-functional teams regarding manufacturing, quality, preclinical, and clinical development, focusing on EU and UK requirements.

Plan and execute regulatory filings.

Collaborate with project teams to resolve complex issues, utilizing regulatory expertise to interpret requirements and secure approvals.

Prepare the company for EMA and other health authority meetings.

Serve as Regulatory Liaison to EMA, MHRA, and other authorities in the EU.

Represent Regulatory Affairs in cross-functional teams.

Manage regulatory risk assessments, communicate findings, and propose mitigation strategies.

Review regulatory documentation, including IMPDs, Clinical Trial Applications, and submissions like BLAs, NDAs, and Variations.

Ensure activities align with project timelines and comply with ICH, FDA, HC, UK, and EU regulations.

Maintain current knowledge of regulatory environments and guidelines.

Interact with partners and consultants on regulatory matters.

Contribute to policy development and external due diligence activities.

Person Specifications B.Sc.

in biological or life sciences; M.Sc.

or Ph.D. preferred.

12+ years of experience in Regulatory Affairs within biotech or pharma industries.

Thorough knowledge of EU and global regulations and biological / drug development processes.

Strong strategic, diplomatic, negotiation, and communication skills.

Ability to interpret technical materials and regulations, with strong technical writing skills.

Knowledge of CMC, clinical, and non-clinical pharmaceutical development.

Broad knowledge of biopharmaceutical manufacturing and operations.

Proven leadership and performance evaluation skills.

CV to Gerry Kennedy, The RFT Group, 01 2302400

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