Job Description
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Posted Date: Jul 7 2023
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
Location: Netherlands – Amersfoort
Language: Fluent in Dutch and good level of English to interact internally within the Haleon organization.
Regulatory Affairs Associate, Benelux
Job Purpose
As a Regulatory Affairs associate BeNeLux, you’ll be part of a team of 7 people located in Netherlands (3 persons) and Belgium (4 persons) and have responsibility over a range of medicinal, medical device, cosmetic & food supplement products. You’ll be closely collaborating with our BeNeLux commercial company stakeholders to look into new innovation strategies, advertising materials & artworks of our products. You’ll also work closely with our Global Regulatory stakeholders to ensure our products remain compliant and changes to the products are progressed in line with the EU & local requirements. Processing changes, keeping products compliance, and looking into innovation, advertising and artworks will also require you to be the contact person with the local authorities/trade bodies for the brands you are responsible for.
You’ll be a key stakeholder for internal local commercial contacts, internal global RA & R&D colleagues & external authority/trade body contacts to help drive our ambition to deliver new self-care solutions to people in our markets & improve and educate people on our existing products (such as Voltaren, Otrivin, Sensodyne, Parodontax, Advil, Centrum, Nicotinell) to ensure people feel empowered & knowledgeable about how to treat their day to day Health issues.
Within our team we value a great team spirit highly and we look out for each other. We focus on sharing knowledge and mentor/train each other on the different BeNeLux RA aspects. Your line manager and the company is committed to ensure you can grow within your role and that you have a personalized development plan in place.
Key responsibilities
- Manage preparation of new regulatory documents, dossiers, and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
- Analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs
- Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance
- Build relationships with key stakeholders and represent Haleon in an appropriate manner according to company values, in order to present Haleon policies and strategies
- Manage compliance within defined portfolio/activity streams in line with Haleon expectations
- support key processes and ways of working (eg, in relation to Haleon CMC, quality, product labelling requirements, artworks as well as local authority regulations)
- Work together with other functions (eg, marketing, supply chain) to deliver innovations and value engineering projects
- Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
- Proactively manage impact of regulatory changes within defined scope of responsibility on the business
- Maintain required regulatory compliance databases, systems and processes
- Maintain high level of knowledge on the science of products within defined portfolio
- Guarantees medical device registration to the National Health Authority databases.
Minimum Requirements:
- Master in pharmaceutical or other life sciences
- Computer literate (Outlook, Teams, …)
- Dutch language
Advantage:
- 1 year of regulatory affairs pharma-industry experience
- French and or German language skills
Why join us?
The future of everyday health is changing. And we’re the people changing it. In front of us is an incredible opportunity to go beyond what any of us have done before. And make everyday health more achievable, more inclusive and more sustainable. For more and more people. So join us, as we build one of the world’s leading consumer healthcare companies. Join us to innovate our category-leading brands. To better understand people’s everyday health needs. To tackle the biggest barriers that stand in their way. To change individual and societal behaviour. Join us to work with colleagues who share your restless energy. To explore your interests. To stretch yourself to do the best work of your career. And join us, as together we build a working experience that encourages us all to lead happier, healthier, more productive lives. The way we see it, every day is an opportunity for better. And we’re going all in to realise it.
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity 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.
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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s compliance to all federal and state US Transparency requirements.
