- Prepare and maintain national labelling (SmPC, PIL and labels)
- Prepare dossiers to meet national submission requirements for new licences, licence renewals, variations, PSURs and DSURs
- Maintain national aspects of global regulatory systems
1. To prepare and maintain national labelling (SmPC, PIL and labels), including checking texts and mock-ups and providing print release of mock-ups.
This includes liaison and negotiation with GRA and Health Authorities (HAs) as appropriate.
2. To prepare, organise and coordinate data / documents to meet national submission requirements for new licences, licence renewals, variations, PSURs and DSURs.
To identify potential problems and provide guidance to authors or team members as appropriate.
This includes review and preparation of Module 1 documentation, placing documentation on docNet and linking to Apollo, submission to HAs as necessary, obtaining approvals and communicating progress to appropriate client personnel.
3. To maintain global regulatory systems and provide input as requested. To review global SOPs and assess their impact on local processes. To develop and maintain local systems and processes, including SOPs and checklists.
4. To maintain national distribution licences and participate in GDP inspections as required.
5. To maintain the registration for our medical devices, currently software apps.
6. To liaise with national functions (medical, marketing, safety, quality, customer services) as necessary to support the national business needs e.g. tenders, product launches, licence information, batch specific variations, unlicensed imports, batch release, quality reviews, audits, etc. To participate in the therapy area Business Team Meetings as necessary.
7. To serve as a subject matter expert at a national level for activities such as changes to national regulations, sunset clause, scientific advice meetings and SOP maintenance.
8. To provide regulatory support to the Recall Team and assistance in communicating with HAs in the event of a recall.
9. To ensure compliance with ALL client Behring UK and client global SOPs, policies and quality system requirements as appropriate to the position including:
· Prompt reporting of all Adverse Events, Product Technical Complaints or Non-Conformities according to UK SOPs
· Completion of required training and maintenance of personal training records
· Providing assistance as required in the event of a field action, as determined by the Recall Team
To ensure that all customer contact and all other company activities and materials remain in compliance with the ABPI Code of Practice and company SOPs.
10. To ensure that all fees are charged correctly and invoices are paid in a timely manner.
Position Qualifications and Experience: Provide hiring criteria (considering areas that are required and those desired) for the specified position, including education, experience and competencies relevant to the position.
· Good Life Science Degree
· Experience of UK and EU Regulatory Affairs.
· Experience of working closely with logistics, medical and marketing functions
· Experience of biological medicines and medical devices
· Experience of liaising with HAs
Functional Technical Skills
Regulatory and Pricing Knowledge and Experience
Relationship Management with Local Regulatory and Pricing Bodies
Attention to Detail