Regulatory Affairs Specialist

Job title:

Regulatory Affairs Specialist

Company:

GlaxoSmithKline

Job description

Regulatory Affairs SpecialistAs Regulatory Affairs Specialist you will be responsible for a specified product portfolio for Denmark and Iceland. This product responsibility includes both national and central licenses and projects still in development. You will act as the subject matter expert and/or key user for one or several expert areas within regulatory department and will be the regulatory expert- providing regulatory expertise on the assigned product portfolio in cross-functional settings to support the business.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 programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; 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 webpageIn this role you will…

• Prepare and submit regulatory applications to the authorities in Denmark and Iceland in compliance with local regulatory requirements.
• 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 local labelling (SmPC, PIL, pack-label and compendium) are updated and consistent with GSK processes and comply with local regulatory requirements.
• Monitor and ensure compliance with local and EU regulatory legislations, guidelines and requirements.
• Provide regulatory input to the organisation for assigned portfolio.
• Represent Regulatory Affairs in cross-functional project groups, to provide regulatory strategic insight
• Other regulatory activities as update of regulatory databases, SOP maintenance and management monitoring

Why you?Qualifications & Skills:

• Degree in relevant subject (e.g. sciences, pharmacy, regulatory) or equivalent
• Fluent in Danish and English, speaking and writing
• Strong IT/digital skills (experience with Veeva Vault is a plus)

Preferred:

• Preferably 1+ years of experience in Regulatory Affairs and understanding of the pharmaceutical industry, and regulatory processes
• Analytical and strategic thinking as well as able to anticipate, identify and solve problems.
• Collaborative approach and enjoy working in a team.
• Able to challenge and see views from different perspectives.
• Ability to handle multiple tasks, to meet constantly shifting priorities and to schedule work to meet business needs
• Able to influence and to liaise with internal and external stakeholders.

Application close date: 30thWhy 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

Vallensbæk Strand, Hovedstaden

Job date

Sat, 18 May 2024 01:59:10 GMT

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