Job title: Head of Regulatory Affairs - UK and Ireland
A global pharmaceutical company with products in Neurology, Oncology and Rare Diseases are seeking a Head of Regulatory Affairs. This is a UK and Ireland affiliate role, leading several cross functional teams. This position will sit on the Affiliate leadership team and report directly into the UK and Ireland General Manager.
- Provide effective leadership and development to the Regulatory, Pharmacovigilance and Quality Management functions
- Provide guidance to the team of experts to ensure full compliance of local & global regulations applicable to the UK & Ireland affiliate
- Ensure that the UK and Ireland Affiliate has a compliant and comprehensive pharmacovigilance and complaint system in place.
- Ensure a local Quality Management System (QMS) is in place in compliance with corporate requirements and national regulations.
- Ensure that the UK and Ireland Affiliate has a compliant and comprehensive regulatory system in place
- Ensure all activities are conducted within the framework and full compliance of EU and national regulatory requirements, Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), Good Distribution Practice (GDP), internal SOPs and company policies, health and safety requirements, the UK and Irish Medicines Acts and Industry Codes of Practice
- At least 8 years work experience, involving direct experience and/or, significant knowledge of Pharmacovigilance, Regulatory and Quality Management Systems experience
- Previous experience with regulatory process management
- Previous experience with medical information and pharmacovigilance
- Previous experience in quality management systems and internal audit / external inspections
- Proven ability to lead a multidisciplinary team of experts
- Proven ability to influence leaders helping them to understand a highly regulated environment
- Extensive UK and Ireland Regulatory experience is a must
- Commercial acumen, Excellent verbal, written, analytical and interpersonal skills
Salary and benefits:
A highly competitive salary, annual bonus, private healthcare, and wider benefits are on offer.
To apply for this position or hear further details then please contact Freddie Hill via Freddie.firstname.lastname@example.org