Oferta pracy

Regulatory Specialist (MSR)

GSKAbout the company

  • Warszawa

    Warszawa, Masovian
  • Offer expired a month 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 local 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

  • Knowledge of worldwide CMC regulatory requirements ( preferred)

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

  • 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

What we offer

  • Remote work (during pandemic)

  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)

  • Established job in an international, well-known pharmaceutical company

  • Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market

  • Opportunity to work within GSK standards and documentation applied globally

  • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)

  • Canteen for employees at site (with discounts)

  • Flexible working hours

  • Benefits

  • remote work opportunities

  • flexible working time

  • 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

Market Specific Requirements within Global Regulatory Centre is accountable for the delivery of all Market Specific Requirements (MSRs) across Global Regulatory Affairs (GRA) across the lifecycle in support of regulatory submissions for Pharma and Vaccines organization.

The purpose for the role will be timely maintenance of Market Specific Requirements (MSRs) in support to various applications. 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. You will have an opportunity to work closely with GRC’s internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRC’s goals.