Regulatory Affairs Specialist CEE

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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