Regulatory Specialist, Product Variations

2 tygodni temu

Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat
Site Name: Poznan Grunwaldzka, Warsaw
Posted Date: Nov

Global Regulatory Centres in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory information management. The Global Regulatory Centres provide regulatory support across the product lifecycle for pharmaceutical, biopharm and vaccines products (clinical development to market maturity).

The Global Regulatory Centre in Poland is creating new roles in the Product Variations team. The purpose for the roles will be leading and participating in global CMC (Chemistry, Manufacturing and Control) variation projects as well as in the Global Supply Chain (GSC) centrally driven change programs (for pharma, biopharm and vaccines products). The Product Variation team is responsible for timely and efficient support of post approval CMC changes, preparation of technical documentation for regulatory changes globally, providing responses to Regulatory Agency questions and expertise in the regulatory requirements for global source changes/CMC variations on Active Pharmaceutical Ingredients (APIs), Intermediates and Drug Products.

Our structures are growing, and we are currently looking for several successful candidates to join our teams.

Your responsibilities
  • Managing multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharma, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)
  • Managing assigned projects: define and agree regulatory 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 Supply Chain, Global Regulatory Groups and GSK Local Operating Companies in markets worldwide to deliver high quality dossiers on time
  • Building and maintaining good relationships with internal and external stakeholders
  • Monitoring regulatory intelligence and acting proactively on identified changes to the regulatory requirements
  • Identifying the improvement opportunities for CMC Regulatory processes, policies and systems
Our requirements
  • Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation)
  • Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry or other related science or technical field
  • Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
  • Attention to detail with emphasis on accuracy and completeness
  • Ability to handle multiple tasks, to meet constantly shifting priorities and to schedule work to meet business needs
  • Flexible and analytical thinking to independently provide solutions to issues
  • Excellent interpersonal skills; ability to communicate clearly and effectively, work in a diverse team environment and build relationships across a large organization
  • Excellent written and verbal communication skills in English
What we offer
  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs), flexible working hours
  • Established job in an international, well-known pharmaceutical company
  • Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets
  • 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)
  • Recognition awards for additional achievements
  • Supportive & friendly working environment
  • Possibilities of development within the role and company's structure

#LI-GSK

# LI-HYBRID

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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 For the Record site.


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