Associate Regulatory Affairs Director

3 weeks ago

Dublin, Dublin City, Ireland Life Science Consultants Full time
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 Gx Ps 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 Grinne Hodnett at LSC on if you have any more questions about this.

Skills: GMP Regulatory Affairs HPRA Senior

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