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Job Details


GlaxoSmithKline (GSK)

Senior Regulatory Affairs Specialist (327109-gsknch)

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

Site Name: Warsaw
Posted Date: Apr 1 2022

In GSK Consumer Healthcare, we are on an incredible journey as we prepare to create a new, standalone, world leading company with a 100% single-minded focus on everyday health. We are doing this at a time when the work we do has never mattered more. With the COVID pandemic, people are increasingly looking for ways to manage their own health and wellbeing and to take care of their families. This is where we come in. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we are uniquely placed to deliver better everyday health to millions of people around the world and grow a strong, successful business. This is an opportunity to be part of something special.

Senior Regulatory Specialist Consumer Healthcare

GSK Consumer Healthcare in Poland is looking for Senior Regulatory Specialist to join Polish Regulatory Affairs Department and support product lifecycle management. This is a temporary assignment due to maternity leave. The purpose of the role is to perform regulatory responsibilities over defined company portfolio consisting of OTC medicine, medical devices and food supplements, to collaborate with Health Authority during submission to approval process, provide input into regulatory strategies and process improvements and contribute to cross functional activities.

Your responsibilities:

  • Ensure preparation of regulatory documents and labelling for variations, notifications and renewals in collaboration with local and global teams
  • Manage routine Regulatory obligations related to product maintenance, in line with respective legislation
  • Maintain required regulatory compliance databases, systems and processes, archive documents in line with company expectations
  • Support product pack updates, final artwork control and ensure its compliance with registered texts
  • Communicate with Global Regulatory groups, answer questions received from Global Regulatory, provide information about status of current and planned projects.
  • Closely collaborate within local Polish Regulatory team as well as with other stakeholders in Marketing, Supply and Quality
  • Work with colleagues in Global Manufacturing & Supply, Global Regulatory Groups and GSK CH Poland to deliver high quality dossiers on time
  • Build and maintain good relationships with internal and external stakeholders
  • Use regulatory intelligence and act proactively on identified changes to the regulatory requirements

Our requirements

  • Minimum 4 years experience in regulatory affairs in OTC medicines company. Experience related to medical devices or food supplements will be an additional asset.
  • Bachelor’s or Master's degree in biotechnology, chemical technology, pharmacy, chemistry or other related science or technical field
  • Good understanding of regulatory processes and relevant legislation
  • Attention to detail with emphasis on accuracy and completeness
  • Good technical skills – to practically operate in internal IT systems
  • Good learning agility and openness to learn and develop expertise about new product categories
  • Resilience and ability to operate in changing environment
  • Flexible and analytical thinking to independently provide solutions to issues,
  • Good interpersonal skills; ability to communicate clearly and effectively, work cross-functionally and build relationships across organization.
  • Excellent written and verbal communication skills in English and Polish

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)
  • Flexible working hours
  • Maternity cover replacement for approx. 20 months

*LI-GSK

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