Regulatory Affairs Manager

Job title:

Regulatory Affairs Manager

Company:

GlaxoSmithKline

Job description

We are seeking a highly motivated Regulatory Affairs Manager to join our team in Amersfoort. You will be part of a diverse and energetic team of 7 colleagues, where you will be responsible for the maintenance of registered products throughout its life cycle, and the registration of new products within your portfolio.Do you have experience in Regulatory Affairs in a pharmaceutical environment? Do you want to work for an innovative company?This might be the role for you.Your key responsibilities:Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with optimized registered Product Information and the correct alignment and compliance to regulationsAnalyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and mitigation plans that are robust and aligned with business needsActively contribute to high performing teams, including looking for ways to improve performance. May lead cross-functional teams and regulatory professionals in the context of a project etc.Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK policies and strategies and negotiate outcomesManage compliance within defined portfolio/activity streams in line with GSK expectations – support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as CBG/MEB regulations). Propose solutions to identified issues and implementWork together with Pack Management Executives to coordinate and approve final artwork and ensure packaging components are printed/produced in line with regulations, GSK expectations and commercial plansCollaboratively working together with other functions (eg. medical, marketing, supply chain, QA) to help implement aRMMS, discontinuations and license withdrawals, to deliver company objectives and contribute to DHPC and product incidents/recalls.Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the businessMaintain required high level of product knowledge within defined portfolio, regulatory compliance databases, systems and processes.Train other company stakeholders as required to build knowledge and compliant utilizationWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Degree in Bio Medical/Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, (Medical) Biology, Medical Engineering)Ideally 3 to 5 years experience in Regulatory Affairs (experience in maintenance of licences and registration of new products)Experience in the pharmaceutical industryDemonstrated excellent verbal and written communication skillsWell-developed time management skills and ability to manage complex assignmentsAnalytical mindset, with an eye for detail and problem-solving skillsHighly proficient in both spoken and written English/ DutchStakeholder managementPreferred Qualifications:If you have the following characteristics, it would be a plus:Master’s or PhD in Pharmacy, Bio Medical/Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, (Medical) Biology, Medical Engineering)Why GSK?At GSK, we have already delivered unprecedented change over the past four years, improving R&D, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. GSK, with its leading portfolio of vaccines and specialty medicines, as well as R&D based on immune system and genetics science.With new ambition comes new purpose. For GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

#Li-GSKWhy 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

Amersfoort, Utrecht

Job date

Tue, 13 Aug 2024 23:02:37 GMT

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