Head of Regulatory Affairs
South East Ireland
Optimize Recruitment have been engaged by a multinational pharmaceutical manufacturer to recruit a Head of Regulatory Affairs to lead a dedicated team of RA professionals in the South East of Ireland.
The successful individual will ensure the provision of all operational and advisory activities relating to regulatory submissions worldwide, timely approvals of product licenses and subsequent license maintenance in a cost-effective manner.
If you would like to join a company with a broad portfolio of healthcare products that change lives daily, please apply today.
Key Responsibilities (include but not limited to):
- Actively contribute to the routine operational use of, and input to, the site Pharmaceutical Quality System by providing functional guidance and support, ensuring the system is used according to defined procedure.
- Plan and execute regulatory strategies for new products to ensure the fastest possible introduction of those products to the market, ensure that new product development programmes are progressed with due regard to regulatory requirements and ensure that all information provided in submissions is of a high standard, complies with regulatory requirements and is presented in a professional manner.
- Support the regulatory compliance of the company with the conditions of its product licences and manufacturing licences.
- Provide an information and advisory service on regulatory affairs to ensure all relevant personnel within the company are briefed on current and future regulatory legislation and requirements.
- Represent the Regulatory Affairs Department at Senior Leadership Team meetings, as well as at internal and external meetings.
- Propose and develop regulatory strategies for new products.
- Assess and advise on the quality of dossiers offered for sale by other companies.
- Identify and address the training needs of the department.
- Review personally or by delegation GMP documentation, including change controls, for regulatory compliance and evaluate the regulatory impact.
- Final sign-off of artwork.
- Educated to at least honours degree level in a life science with at least 10 years’ experience in RA in an international role.
- Membership of The Organisation for Professionals in Regulatory Affairs (TOPRA) is essential.
- Ability to motivate and manage subordinates and colleagues.
- Requires the ability to present the Company’s interests in a professional and authoritative manner and to conduct negotiations with regulatory bodies at the highest level.
- Uses good judgement and can make effective decision on complex issues.
- Exceptional ability to leverage/collaborate effectively with internal and external stakeholders.
For more information on this role, please contact Lee Doheny in the strictest of confidence on 0858072559 / email@example.com
Please note your CV will never be released without your expressed permission.
JOB REF: LD-22433