Associate Regulatory Affairs Director (BBBH28356) Dublin, Republic of Ireland
LSC have a great contract opportunity for an Associate Regulatory Affairs Director to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT THE PROJECT - KEY 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.
* 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 behaviour, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* 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 our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available at this time. Thank you for your attention.
Apply via this advert or contact Gráinne Hodnett at LSC on 021-4777329 if you have any more questions about this.
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