Director, Regulatory Affairs

The RFT Group

Director, Regulatory Affairs Dublin pharma

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 products and existing commercial products. Job Summary The Director, Regulatory Affairs will oversee regulatory activities across our product portfolio. The Director Regulatory Affairs is responsible for providing strategic direction to the business and other stakeholder functions as it pertains to EU & global licensure of company products. The Director is responsible for leading the development and implementation of RA strategies and establishing optimal regulatory positions for full product portfolio and maintaining the licenses of existing commercial products. Job Spec

· Directs and develops regulatory group located across company sites or remotely located

· Develop and lead regulatory strategy, for the EU and global, for all products

· Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products with a focus on EU and/or UK requirements

· Directs efforts for planning and execution of required regulatory filings

· Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.

· Prepare company team for EMA or and other health authority meetings

· Serve as Regulatory Liaison to the EMA, MHRA, or local Member State Health Authorities in the EU (and other regulatory authorities) for assigned projects

· Represent Regulatory Affairs at cross-functional teams core teams

· Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches

· Provide critical review of documentation supporting regulatory applications including, but not limited to, pre-IMPD and formal meetings with health authorities, IMPDs, Clinical Trial Applications, Annual Reports, BLAs, NDAs, MAAs, Variations and BLA supplements

· Ensure RA activities are aligned Project timelines & business objectives and are in compliance with ICH, FDA, HC, UK, and EU regulations

· Maintain knowledge of regulatory environment, regulations and guidance’s.

· Interact with company partners and consultants for various regulatory matters as needed

· Contribute regulatory perspective as needed on government proposals and external due diligence activities

· Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs

· Responsible for department budget

Person Spec

· B.Sc. degree in related biological and life sciences field (M.Sc. or Ph.D. preferred)

· 12+ years directly related experience in Regulatory Affairs, in biotechnology or pharmaceutical industry.

· Knowledge of EU and global regulations / guidance’s and thorough knowledge of biological/ drug development process required.

· Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.

· Strong decision-making abilities

· Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development,

· Possess a broad knowledge of biopharmaceutical manufacturing and operations.

· Demonstrated people-leader skills and evaluation of performance.

CV to Gerry Kennedy The RFT Group gerry@rftgroup.ie 01 2302400