Job title:
Regulatory Affairs Specialist CEE
Company:
Aspen Pharmacare
Job description
Description
- Review of regulatory aspects of local contracts and agreements
- Act as a single point of contact with National Medicines Verifications Systems
- Work as part of a multi-disciplinary team on projects as and when required, providing regulatory input and guidance
- Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times
- Ensure that any regulatory changes communicated to the pharmaceutical industry by regulatory authorities are communicate to the Head of RA Poland & CEE and Head of RA (Europe) so that they are implemented without delay and impact assessment is performed
- Implement Standard Operating Procedures where relevant to the regulatory function
- Implement regulatory trainings of all regulatory personnel in the countries within the cluster
- Ensure that accurate records are kept and maintained in a secure manner as per Good Documentation Practice; ensure proper data management and archiving
- Assist with customer complaints handling to ensure they are dealt with efficiently and effectively and in accordance with the technical agreements
- Assist in recall/quality defect/waiver/out of stock activities as required on behalf of the MA holder and notifications to HAs
- Review and approve artworks of PILs, labelling in line with Standard Operating Procedure and initiating mock-up requests in time to meet planned submission dates
- Implement labelling updates and verify correctness on pharmaceutical sections. Update product information in national formularies. Organize translation service for PILs to local language
- Promotions and Marketing – ensure promotional and non-promotional material of medicinal products are compliant with national legal requirements, are available and documented, incl. proof-reading vs current version of the approved local product information and sign off promo materials, sales force detailing, websites, educational material and in post-marketing studies.
- Any other duties as assigned by Senior Management
Requirements
- High level education such as BSc, MSc, PhD or Pharmacist in Life sciences or related area
- At least 3-5 years in a similar role in Regulatory in the pharmaceutical industry multiple
- Ability to communicate effectively in English, verbally and in writing
Work LevelSkilledTypePermanentSalaryMarket RelatedEE PositionNoLocationWarsaw
Expected salary
Location
Warszawa, mazowieckie
Job date
Sat, 05 Apr 2025 03:43:34 GMT
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