Head of Regulatory Affairs and Quality
On behalf of my client, a leading healthcare company we are working with them on a new opportunity for a Head of Regulatory Affairs.
SUMMARY OF POSITION
You will have responsibility for the development and implementation of the Regulatory strategy to support the business objectives of the company.
Responsible for Quality and Pharmacovigilance (PV) pertaining to the company and its products.
Your role will represent the Company with Regulatory partners, Health Authorities and other professional bodies to ensure that professional working relationships are developed and that a positive image of the Company is maintained. Responsible for all regulatory, quality and PV related external interactions, including, but not limited to authorities, professional bodies, partners, and contract manufacturing and development companies.
· Oversee Regulatory, Quality and Pharmacovigilance functions for Ireland and UK and complete any key tasks as required.
· Responsible for the timely reviews of all relevant regulatory projects and documents relating to development programmes.
· Determine strategy for submissions, change of registration documents and extensions in support of new products and new territories as required by Company. Responsible for planning and coordinating all aspects of regulatory submissions and licenses maintenance. In addition, responsible for review of scientific documents intended for submission to Regulatory Authorities.
· Carry-out regulatory due diligence as required in product acquisitions.
· Establish and maintain regular and effective interface with regulatory officials and other Authorities.
· Manage key interactions with Regulatory Authorities including quality defects and recalls.
· Manage products under threat due to regulatory or quality or safety issues.
· Lead meetings/teleconferences with regulatory authorities and external companies and assure that the outcomes of are clearly documented, understood and agreed upon by all participants.
· Identify and clearly communicate all regulatory, PV and quality issues related to projects and Products to the CFO/COO and MD.
· Maintain current working knowledge relating to EU regulatory, PV and quality requirements and provide advice on any business impact.
· Provide guidance to peers regarding Regulatory, PV and Quality issues.
· Ensures the Company complies with the requirements of the “MA Holder” status under EU and relevant international regulations.
· Management of budget and costs.
· Management of third-party PV provider and Vendors from acquisitions.
· Essential: Degree in Chemistry, Pharmacy or allied subject.
· Ideal: Ph.D in Chemistry, Pharmacy or allied subject.
· Minimum 8-10 years broad pharmaceutical industry experience in EU Regulatory Affairs (small and large molecule experience a plus) and “standard” product areas.
· Must have previous experience leading interactions with Health Authorities.
· Experience of working within the Regulatory and Quality functions within an international pharmaceutical company and an understanding of the legal and regulatory requirements.
· Knowledge of and experience managing or being part of pharmacovigilance within an international pharmaceutical company and an understanding of the statutory requirements.
· Solid knowledge of CMC issues through direct experience working with a pharmaceutical company managing at least one Tech Transfer as the responsible person.
· Previous direct experience with development programs through registration strongly preferred.
· Solid knowledge of EU GDP and GMP.
· Knowledge and experience in EU Medical Devices, Cosmetic and Food regulations preferred.
· Experience building new dossiers as well as maintaining existing dossiers very beneficial.
For full job spec and details contact Tina at +353 1 2784671 or email your CV to firstname.lastname@example.org
Thornshaw Scientific is a division of the CPL Group. www.thornshaw.com