Regulatory Specialist, Product Variations

Descripción de la oferta

Nombre del sítio: Poznan Grunwaldzka, Warsaw
Fecha de publicación: Nov 14 2023

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

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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)

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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

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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

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Building and maintaining good relationships with internal and external stakeholders

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Monitoring regulatory intelligence and acting proactively on identified changes to the regulatory requirements

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Identifying the improvement opportunities for CMC Regulatory processes, policies and systems

Our requirements

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Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation)

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

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

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Attention to detail with emphasis on accuracy and completeness

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Ability to handle multiple tasks, to meet constantly shifting priorities and to schedule work to meet business needs

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Flexible and analytical thinking to independently provide solutions to issues

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Excellent interpersonal skills; ability to communicate clearly and effectively, work in a diverse team environment and build relationships across a large organization

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Excellent written and verbal communication skills in English

What we offer

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

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Established job in an international, well-known pharmaceutical company

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Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets

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Opportunity to work within GSK standards and documentation applied globally

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

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Recognition awards for additional achievements

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Supportive & friendly working environment

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Possibilities of development within the role and company’s structure

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