Director Of Regulatory

CPL

Dublin City Centre

My client is an International Pharmaceutical company and have just engaged in a very exciting chapter and have set up their new commercial offices based in Dublin City Centre. They are an established leader in injectable oncology and dermatology products. In conjunction with the CPL Group they are looking to recruit for a Director of Regulatory Affairs. Reporting to the General Manager, The Director of Regulatory is responsible for developing and implementing regulatory strategies for EU registrations and for determining the best regulatory path/action for device and generic drug products in development and post-approval phases. Essential Duties & Responsibilities Direct strategy for Regulatory Affairs to meet established company goals. Define and manage external advisor/consultants required to meet company goals. Act as advisor to peers and subordinates to meet schedules/goals and resolve technical and procedural problems. Develop and implement budgets, timelines and performance requirements. Develop regulatory strategies for domestic and international registrations and determine best regulatory path/action for device and drug products, both in development and post-approval. Manage development and post-approval registration. Represent company as liaison with regulatory agencies. Function as senior regulatory advisor on project teams when needed. Ensure regulatory documentation meets set standards and adheres to established regulatory strategy. Monitor progress of regulatory projects and responsibilities. Direct labeling function. Evaluate workload and resources relative to company and department goals. Procure appropriate consultants and contract research organization(s) to address registration and labeling needs. Knowledge, Skills & Abilities Strong working knowledge, ability to understand and interpret EU and international governmental regulations/guidelines and apply them so that regulatory requirements are met. Demonstrated record of success in gaining regulatory approval in the EU. Ability to coordinate inter-departmental personnel to contribute to regulatory documentation. Education & Experience Bachelor’s or Master’s degree in a scientific field. Ten or more years’ experience in Regulatory Affairs in the pharmaceutical/biotech industry with the responsibility for preparing and submitting electronic regulatory applications to regulatory agencies. RAC certification. Suitable candidates should email their cv to aileen.cahill@cpl.ie or call me on 01-6146007 for a confidential conversation today. This job originally appeared on RecruitIreland.com.

2487 days ago