Associate Director Regulatory Affairs

Overview

Associate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function.

Responsibilities

• Developing and implementing global regulatory strategies for assigned products.
• Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
• Providing input to submission strategy and other critical regulatory documents. May act as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
• May provide input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
• Actively being up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
• Support regulatory intelligence and policy priorities based on internal knowledge and expertise.
• Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Desirable experience/Qualifications

• Extensive Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
• Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgement.
• Experience providing strategic regulatory advice for the global development of products through all stages of development including marketed assets.
• Successful track record in registering and overseeing regulatory strategies for assets.
• Bachelor's Degree, life science highly desirable
• Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus

If this role is of interest, please apply now.