Description
We are looking for a
Regulatory Labelling Manager (m/f)
Reference: -en
Start: 12/16
Duration: 13 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsible for supporting the development of and managing the maintenance of Core Data Sheets (CDS) and associated product information documents
- Provide strategic labelling support to teams and generate labelling scenarios for products throughout their development and maintenance lifecycle
- Take over the lead and responsibility for complex CDS maintenance and development activities including the planning, creation of timelines and project management for CDS activities
- Provide support for other CDS-related activities and initiatives as required
- Support the implementation of CDS changes into the Local Product Labels (LPLs) and take part in tracking local label compliance and local label deviations
- Support the review process for product label changes (e.g. from health authorities)
- Provide competitive labelling comparisons as required for CDS preparation
- Support the Labelling Management team in the training of Program and Product teams on CDS policies and procedures
- Maintain an overview of relevant global regulatory labelling requirements
Your qualifications
- B.Sc. in a life science subject or in a closely related discipline and solid experience/expertise in regulatory affairs (preferably labelling)
- Experience of developing or maintaining core data sheets for medicinal products
- Excellent team working skills with well-developed interpersonal skills
- An accomplished communicator with good written and verbal communication skills
- Ability to successfully plan and organise your own workload
- Committed to producing high quality outputs and demonstrate excellent attention to detail
Skills:
- Regulatory affairs manager