(Senior) Regulatory Affairs Associate (London area)
Company: TEC Group International
Closing Date: 13 Mar 17
Salary (£): 40,000 - 60,000
Benefits: Full package
For more info on this or other positions please contact Sam Murphy via email or phone. email@example.com / 0044 (0) 208 544 3423
Key areas of responsibility
- · Management of packaging materials from submission to implementation
- · Key contact for supply chain colleagues with regards to implementation of artwork
- · Compile and submit regulatory licence submissions
- · Checking regulatory accuracy and Code compliance of marketing materials and performing review through the 'Zinc' system.
- · Coordination of changes through the company change control system
- Knowledge of current legislation, any changes to the European and National requirements is up to date and perform departmental training of relevant changes
Packaging material management:
- · Request and get approval for mock-ups and artwork changes using the relevant global or local system as appropriate, in line with company standard lead times and business requirements.
- · Manage local packaging specifications to include update and archive in line with local procedures.
- · Ensure compliant and on time implementation of packaging material into the marketed packs following regulatory approval.
- · Ensure robust systems are in place for tracking and monitoring artwork through from submission to implementation in alignment with the regulatory affairs team. Act as departmental expert in corporate system ‘D2’ for creating submission mock up and print proofs for packaging materials.
- · Maintain full awareness of the relevant legislation and guidance concerning the labelling and leaflets associated with medicinal products.
- · Act as key contact for commercial teams to ensure clear communication regarding timings for artwork related changes.
- · Facilitate good relationships with local and global manufacturing and packaging functions to aid product compliance with a focus on packaging materials.
- · Compile, review and submit regulatory licence submissions to UK/Ireland regulatory authorities, in line with the UK and European regulations and the company processes. Liaise with the Groups Companies, associate companies, licensors and business partners to obtain the necessary information to compile successful submissions to the Regulatory Authorities.
- · Status of dossier compliance to be assured at all times.
- · Perform post-approval activities. Monitor all regulatory submissions, approvals and reconciliation of Regulatory changes through to implementation.
- Promotional Material Reviewer:
- · Undertake the review of promotional materials in the capacity of Regulatory Affairs reviewer in compliance with the ABPI code and EU regulation.
- · Ensure Head of Regulatory Affairs is aware of any potential system gaps and risks of non-compliance.
- · Act as departmental expert in corporate system ‘RIMS’ (Regulatory Information Management System). Ensure database accuracy for UK/Ireland entries.
- Manage and track departmental activities through the corporate TrackWise system to communicate and coordinate submissions and to ensure actions take place on time. Entries into TrackWise to be checked for correctness and completeness to ensure efficient change control.
- Write/update relevant working procedures in support of the above listed activities.
- Contribute to internal/external regulatory audits/inspections as required.
- Ensure that any information in relation to a potential adverse event is transmitted to the UK Pharmacovigilance Department within 24 hours of receipt.
Maintain the regulatory department’s awareness of Regulatory legislation, national requirements and guidance in the UK and Ireland.
Carry out departmental training to cover any changes to legislation, guidance, authority best practices and internal company (global and local) procedural changes.
Provide competitor intelligence to commercial functions.