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.

As Regulatory Affairs Manager, you will be the regulatory specialist responsible for a specified product portfolio, including both national and central licenses, and projects still in development. You will act as a Subject Matter Expert and/or Key User for one or several expert areas within regulatory department and will provide regulatory expertise on the assigned product portfolio in cross-functional settings to support the business.

In this role you will…

• Prepare and submit relevant regulatory submissions of high quality and in compliance with local regulatory requirements and GSK Processes and Policies, in a timely manner.
• Ensure effective interaction with authorities to support local/central functions for assigned activities. Respond to questions from the authority in collaboration with the Headquarter.
• Ensure high quality local labelling (SmPC, PIL, pack-label, artwork and compendium) are updated and consistent with GSK Regulatory Processes and Policies and to comply with local regulatory requirements
• Keep fully aware of local and EU regulatory requirements and GSK Regulatory Processes and Policies
• Build/maintain local/central and external relationships to support assigned product portfolio and expert area.
• Participate in central project groups, when relevant, to ensure an optimal regulatory strategy is implemented.
• Work with supply and business to mitigate consequences of stock-out situations.

Why you?

Qualifications & Skills:

• Degree in relevant subject (e.g. Biomedicine, Pharmacy, Biochemistry) or equivalent degree
• 3+ years’ experience in Regulatory Affairs
• Fluent in Swedish and English, speaking and writing
• Strong IT/digital skills (experience with Veeva Vault is a plus)

Preferred:

• Analytical and strategic thinker. Able to anticipate, identify and solve problems.
• Attentive to details. Good organizing and planning ability
• Able to take responsibility and provide leadership
• Collaborative approach and enjoy working in a team
• Able to challenge and see views from different perspectives. Able to influence and to liaise with internal and external stakeholders
• Understands both business content and issues in the external environment

Application close date: 3rd September

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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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