Oferta pracy

Regulatory Specialist - Market Specific Documentation

GSKAbout the company

  • Poznań

    Poznań, Greater Poland
  • Offer expired 25 days ago
  • Remote recruitment
  • contract of employment
  • full-time
  • specialist (Mid / Regular)

Your responsibilities

  • Managing Market Specific Requirements for Finished Products and Active Pharmaceutical Ingredients in various areas

  • Complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for specific markets

  • Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time.

  • Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements.

  • Understand external/internal Regulatory environment.

  • Building good relationships with internal and external stakeholders.

Our requirements

  • Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)

  • Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field

  • Attention to detail, excellent organization and time management skills

  • Excellent written and verbal communication skills in English and Polish

  • Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues

  • Understanding of the pharmaceutical industry, drug development environment, and regulatory processes

Optional

  • Knowledge of worldwide CMC regulatory requirements

  • Work experience in an international environment would be an additional advantage

  • Work experience in biopharma and vaccines is highly welcomed

  • Benefits

  • retirement pension plan

  • leisure zone

  • extra social benefits

  • holiday funds

  • charity initiatives

  • one shorter working day

  • life Insurance

  • sport and recreation cards

  • annual bonus

  • canteen for employees at site (with discounts)

  • flexible working options available for most positions

GSK

Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity, product expansion dossiers, labeling outputs, license maintenance, regulatory information. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity) across various markets worldwide.

The purpose for the role will be timely maintenance of Market Specific Requirements (MSRs) documentation in support to various applications submitted in affected markets. Regulatory Specialist is accountable for delivering MSRs documentation in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licenses and new applications worldwide.

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