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Job Details


GlaxoSmithKline (GSK)

Regulatory Regional Coordinator

Pharmaceuticals

All

Full Time

On Site

No

Warsaw, Indiana, United States

Site Name: Warsaw, Poznan Grunwaldzka
Posted Date: Oct 5 2022

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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Find out more:

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We have established a new cross market operation in central and southern parts of Europe (Partnership Markets), working with strategic partners to commercialise and distribute our medicines and vaccines.

Our Regional Regulatory Coordinator will lead on regulatory operations to support the Partnership Markets, including oversight and coordination of the operational matrix between Global Regulatory teams and 3rd party partners.

The scope of your responsibilities will include:

  • Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with Global Regulatory and 3rd Party Service Provider and to support regulatory submissions to local regulatory agencies.

  • Effective planning and tracking of regulatory activities for defined markets.

  • Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning.

  • Ensures that GSK product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labelling are compliant with MA and with regulatory requirements and available in local language for Health Care Practitioners.

  • Co-ordinates the completion of local language translations by 3rd Party CRO (Product Information, regulatory submissions and agency responses and market communications).

  • Co-ordinates responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.

  • Co-ordinates with Global Regulatory the management of product registration documents and agency correspondence in regulatory databases and repositories.

  • Ensures that responses to Regulatory agencies regarding product quality and safety issues are made in an expeditious manner in accordance with company procedures.

  • Provides considered regulatory advice, leadership and expertise to commercial and to other cross functional groups.

  • Builds and maintains effective relationships with internal regulatory, medical, quality, commercial, & supply chain groups.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Degree in scientific discipline (life sciences / pharmacy / professions aligned to medicine).

  • Min. 4 years of relevant experience in Regulatory Affairs.

  • Knowledge of the policies and regulatory climate in Europe.

  • Experience gained across various markets is preferred.

  • Experience of working effectively in a matrix across functions.

  • Fluent English language skills (speaking and writing)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Effective collaboration and negotiation with regulatory agencies.

  • Work in complex regulatory environment. Able to anticipate possible changes in the regulatory environment (relating to product development, NPI, and market access) proactively, to monitor their implementation, to assess and communicate possible risks and to prepare the mitigation strategy.

  • Well-developed and demonstrable skills working as a member of a multi-functional team.

  • Ability to multi task and excel in cross-functional settings and to manage multiple issues in a fast-paced environment.

  • The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management.

What we offer:

  • Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer

  • Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services)

  • Hybrid working model

  • Career at one of the leading global healthcare companies

  • Supportive & friendly working environment

  • Corporate culture based on our values: patient focus, integrity, respect and transparency

*LI-GSK

*LI-HYBRID

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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 1-[Register to View] (US Toll Free) or +1 [Register to View] (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.

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