Regulatory Specialist
GSK
Poznan Grunwaldzka, Poland
‎1 godz. temu

Your Responsibilities :

The Global Regulatory Platform and Delivery team are creating new roles in the CMC Variations Poznan team. The purpose for the role will be leading or participating in global CMC Variation projects (for Pharma and Vaccines Products), timely maintenance of post approval CMC changes for Finished Product and Active Pharmaceutical Ingredients, providing expertise and support to Local Operating Companies with respect to post approval changes and responses to Regulatory Agency questions about Products.

As our structure is growing, we are looking for several successful candidates to join our teams.

Key responsibilities :

  • Managing multiple CMC (Chemistry, Manufacturing and Control) Variations assignments for Finished Products and Active Pharmaceutical Ingredients for Pharma and Vaccines products
  • Define and agree strategy, complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets e.
  • g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions, US and International countries)

  • 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
  • Building good relationships with internal and external stakeholders
  • Ensuring all appropriate regulatory aspects for product release and stability are in place, to ensure continuity of market supply
  • Basic qualifications :

  • 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.
  • We offer :

  • 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
  • Partly remote work
  • LI-GSK
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

    GSK is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

    This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements.

    For more information, please visit GSK’s Transparency Reporting site.

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