Global Regulatory Affairs Expert Wanted
A leading biopharmaceutical company in Dublin is seeking an experienced Associate Regulatory Affairs Director to join their team. The ideal candidate will have a strong track record of developing and implementing global regulatory strategies for assigned products.
* Developing and implementing global regulatory strategies for assigned products.
* Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
* 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.
* Ensuring exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities, and other external stakeholders.
To succeed in this role, you should have:
* BSc in Science or Engineering.
* 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.
* Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
* Strong interpersonal and written/verbal communication skills.
* Proven track record practicing sound judgment as it relates to risk assessment.
* 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.
For this contracting position in Ireland's pharmaceutical industry, applicants must possess a Stamp 4 visa. Visa sponsorship is not available at this time.
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