Role descriptionRole: Director Regulatory, CMC and Quality
Package: Competitive basic salary 120-150K (Euro)
Location: Head Office - Dublin
Role Type: Director of Regulatory Affairs, Regulatory Affairs
The client is an integrated healthcare company operating in the prescription and OTC market segments with an ambitious growth plan across a range of pharmaceutical activities
The Directory of Regulatory will be responsible for all matters pertaining to the Regulatory function within the company and all external interactions, including, but not limited to authorities, bodies, partners, development and manufacturing and development companies. To be the Responsible Person and to manage all Quality related matters pertaining to the company and its products. To be the internal owner and to communicate internally all relevant issues, objectives and opportunities and to be responsible for delivering change. To ensure the company abides by all relevant rules and regulations. To be an active member of the company management team, inputting from a technical and business perspective and to work to help the company deliver growth across the current and future portfolio.
Key Accountabilities will include:
Provide recommendations to the Project Team and/or Management on regulatory direction for development projects and approved products for incorporation into the development strategy.
Establish and maintain regular and effective interface with regulatory officials and other authorities.
Determine strategy for submissions/ change of registration documents and extensions.
Responsible for the timely reviews of all relevant regulatory projects and documents relating to development programmes.
Lead meetings/teleconferences with regulatory authorities and external companies and assure that the outcomes of are clearly documented, understood and agreed upon by all participants.
Identify and clearly communicate all regulatory, CMC and quality issues related to projects and Products to the Management Team.
Maintain current working knowledge of global relevant regulatory, CMS and quality requirements.
Lead meetings updating status of regulatory activities and contribute to the establishment of regulatory strategies for new products and processes.
Provide guidance to peers regarding regulatory, CMS and quality issues.
This role reports to the COO/ CEO and will manage regulatory direct reports. Regular contacts including Quality, Logistics, Marketing, R&D, Site Production Leaders as prime consultant and external spokesperson for the organization on highly significant matters relating to policies programs, capabilities and long-range goals and objectives.