Summary:
An Associate Regulatory Affairs Director is required for a biopharmaceutical company in West Dublin.
The role involves leading global regulatory strategies for assigned products, supporting registration and lifecycle management.
The successful candidate will provide regulatory input to global programmes and maintain strong relationships with internal teams and regulatory authorities.
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 company objectives through initial registration and subsequent lifecycle management.Providing input to submission strategy and other critical regulatory documents.
May represent the company as point 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 the company's internal knowledge and expertise.Ensuring exemplary behaviour, leadership, ethics and transparency within the company, with Health Authorities and other external stakeholders.Qualifications & Experience: Bachelor's Degree in a life science related field, and a postgraduate degrees relevant to the role (e.g.
MSc, PhD) would be a plus.7+ years of 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 judgment.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.Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.Highly conversant and knowledgeable of new and emerging regulations and guidances.
Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
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