Join to apply for the Regulatory Affairs Department Head role at Helsinn Group.
We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team, and ensuring compliance with applicable requirements for our pharmaceutical products.
This position requires a combination of supervision responsibilities and hands-on involvement in regulatory operations, with a focus on GMP compliance, regulatory quality assurance, and CMC-related activities to support our manufacturing site.
Position Overview
Lead the Regulatory Affairs team in Ireland, ensuring high performance and compliance.
Oversee regulatory activities including submissions, compliance, and documentation.
Coordinate with global regulatory teams and internal departments.
Required Qualifications and Experience
Degree in Pharmacy, Life Sciences, or related field; postgraduate qualifications are advantageous.
At least 7 years of experience in Regulatory Affairs within the pharmaceutical industry, including management roles.
Experience with CMC regulatory activities and documentation.
Knowledge of European regulatory requirements and ROW markets.
Proven leadership, project management, and cross-functional collaboration skills.
Strong understanding of GMP, GDP, and pharmaceutical quality systems.
Key Responsibilities
Manage and develop the Regulatory Affairs team.
Oversee regulatory submissions, including MAAs, variations, and renewals.
Ensure compliance with GMP and regulatory quality standards.
Serve as the primary contact with regulatory authorities.
Collaborate with internal teams to ensure regulatory compliance and support organizational changes.
The Company
The Helsinn Group has a presence in over 90 countries, specializing in Oncology Supportive Care, Pain, and Inflammation medicines. The role is based at Helsinn Birex Pharmaceuticals Ltd in Damastown Industrial Estate, Mulhuddart, which develops and manufactures finished pharmaceutical forms.
Benefits
Health Insurance
Performance Bonus
Car Allowance
Pension Scheme
Parking with EV Charger
Flex Time
Work from Home Scheme
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