Associate Director Regulatory Affairs

4 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

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.
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