Description
The role:
The Regulatory Affairs Manager will be responsible for:
- Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
- Develop professional working relationships with assessors and administrative staff within the regulatory agencies
- Prepare high quality regulatory applications and regulatory responses for UK/Ireland/Malta Defend existing labelling and provide regulatory input into patent defence strategies
- Ensure timely submission of all licence variations and renewals and compliance with UK/Ireland/Malta licences
- Ensure clinical trial applications are filed to target, and amended to remain in compliance
- Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs
- Provide regulatory input/solutions to stock issues
- Liaise with Operations to manage pack changes and ensure labelling compliance
- Deliver the brand/commercial objectives, including representing Regulatory Affairs on Brand Lifecycle/Campaign Development/Customer shaping teams as appropriate
- Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence
- Take a lead role in project management and delivery
- Understand and promote UK/Irish business needs into European strategies on drug development and regulatory filings/issues
- Ensure appropriate cross functional input into the delivery of optimal licence strategies
- Keep up-to-date with developments in the Regulatory Environment and share this knowledge across the department and beyond, in the business interest
- Ensure departmental processes and organisation are continuously reviewed for creativity, efficiency and productivity (including leading one-off major projects
- Actively contribute to cross-functional team working within the Medical & Regulatory Directorate and other areas of the business
- Responsible for planning and executing workload for the defined product responsibilities and agreeing plan with Regulatory Team Manager
Qualification
- Life Sciences Degree or equivalent
- Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
- Experience of working with submissions in UK and Europe