Description
As a Regulatory Affairs professional at Pfizer, you will conduct strategic regulatory activities to obtain and maintain Marketing Authorizations and support Clinical Trial Applications. You will work under the supervision of line management or guidance from an experienced Senior Regulatory Manager.
Key Responsibilities:
- Deliver regulatory strategy and advise cross-functional teams
- Provide regulatory advice and information to meet customer and cross-divisional colleague requests
- Manage new registration/marketing authorization applications, marketing authorization variation applications, and marketing authorization renewal applications
- Manage National Regulatory Authority (NRA) queries and develop knowledge of NRAs' expectations
- Support strategic clinical development activities in partnership with national Regulatory Authorities and Clinical Trials Regulatory Strategy Execution (CTRSE)
- Populate and maintain regulatory databases
- Obtain NRA approvals for supply of unlicensed medicines
- Safeguard compliance in the management of packaging and prescribing information component updates
- Support MA divestments, MA cancellations, product discontinuations, and supply continuity
- Support third-party licenses and regulatory activities for medical devices
- Contribute to good regulatory practice (GRP) and support regulatory group development
- Lead personal development
Requirements:
- Life sciences or chemistry graduate to honors level or equivalent
- Master's degree, Post Graduate Diploma or PhD preferred
- Relevant professional qualifications desirable (e.g. MSc in Regulatory)
- Previous experience and proven track record in Regulatory (Human Medicinal Products) in UK & Ireland
- Computer literacy
- Excellent written and verbal communication skills
- Proven strength in analytical thinking