HOT JOB! - Senior Regulatory Affairs Officer - Reading, Berkshire (GB)
To maintain marketing authorisations for a portfolio of products, liaising with Marketing, Medical, Supply Chain, QA/ QP, Pharmacovigilance and STADA teams and communicating key regulatory issues that may affect marketed products, products in development or new product launches.
Develop and gain agreement for submission strategies for all CMC and safety changes either internally driven or by changes in regulation.
Development and maintenance of regulatory Standard Operating Procedures and working instructions as required. Maintaining commercial awareness of current and new legislation/ guidance to ensure that work is compliance with the statutory requirements.
Gaining marketing authorisations for pharmaceutical products in the new countries as determined by business requirements.
- KEY ACCOUNTABILITIES
- Prepares, submits and coordinates national Marketing Authorisation Applications in accordance with Global submission requirements
- Finalises and co-ordinates with local partners the national phase of Marketing Authorisation. Applications submitted via the EU Mutual Recognition/ Decentralised Procedures/Centralised Procedures (generation of local text and artwork)
- Ensures submissions are made in agreed timeframes and in line with current health authority regulations to support department schedules/ priorities for launch and maintainace
- Updates relevant functional stakeholders of any delays and/or schedule conflicts in fulfilling regulatory plans
- Liaises with Artwork Coordinator regarding preparation/ approval of mock-ups
Life Cycle Management
- Complies and submits CMC variations (CP/DCP/MRP/ National) in line with variation regulations, SOPs (where relevant) and national Competent Authority requirements
- Complies and submits labelling variations (CP/DCP/MRP/ National) in line with variation regulations, SOPs (where relevant) and national Competent Authority requirements
- Complies and submits renewals (where relevant) prior to MA expiry in line with variation regulations, SOPs ( where relevant) and national Competent Authority requirements
- Monitors timelines for generating/ submitting new launch, renewal and variation documentation on a monthly basis
Submissions & Regulatory Affairs Databases
- Compile the regulatory documents in eCTDformat using documentum and publishing tools
- Update and maintain the regulatory databases as needed (Global Regulatory systems and team trackers)
- Requests appropriate sites licences from MHRA
- Maintains the company’s exiting site licences
- Submits ‘Notification of Intention to import’ Unlicensed Relevant Medicinal Products applications, when and if required
- Supports our Global partners to obtain GMP accreditation of contract manufacturing sites, where appropriate
Regulatory/ Quality Assurance Compliance
- Provides Britannia QPs with current licence information to ensure product is released to respective markets in compliance with their registered technical details in that market.
- Ensures regulatory documentation is appropriately archived
- Ensures that specifications and labelling are appropriately controlled
- Raises Change Controls for regulatory activities within the department
- Creates and maintains SOPs and Work Instructions for the Regulatory function
- Supports Regulatory inspections, internal audits and departmental self-inspections
- Mentors junior team members
- Acts as a delegate for Regulatory Affairs Senior Manager in meetings where appropriate
- Represents the department in key meetings and independently makes decisions on behalf of the department