As Regulatory Specialist / Senior Regulatory Specialist you will be responsible for the CMC regulatory activities required during lifecycle of GSK products. You will work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to create proper CMC post-approval variation dossiers on Active Pharmaceutical Ingredients (APIs), Intermediates and Finished Products.

You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programme and pension plan membership.

We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Key Responsibilities:

• Managing multiple CMC variations and source transfers of GSK’s APIs, Intermediates and Finished Products (work with the CTD Module 3, the Quality part of the dossiers).

• Managing assigned projects, ensuring the authored regulatory dossiers are in compliance with GSK regulatory processes and external local requirements in e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions), US and International markets.

• 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.

Why you?

Basic Qualifications:

• 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.

• Understanding of the pharmaceutical industry, drug development 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.

Benefits:

• Career at one of the leading global healthcare companies.

• Attractive reward package (competitive salary, annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit.)

• Possibilities of development within the role and company’s structure.

• Life insurance and pension plan.

• Open and inclusive environment which is supportive and welcoming of all diversity strands (gender, race, ethnicity, sexuality, disability, or any other characteristic).

• Private medical package with additional preventive healthcare services for employees and their eligible counterparts.

• Sports cards (Multisport).

• Personalized learning approach (mentoring, online trainings’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external trainings).

• Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities).

• Supportive community and integration events.

• Modern office with creative rooms, fresh fruits everyday.

• Free car and bike parking, locker rooms and showers.

Inclusion & Diversity at GSK:

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (pl.recruitment-adjustments@gsk.com) to further discuss this today.

#LI-GSK #LI-Hybrid #DEI

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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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