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Over de functie
You probably use the toothpaste, pain relief products or their respiratory products of this well known A-Brand international FMCG company.
Now is the chance to join their team for an assignment of six months as a Regulatory Affairs Associate and help customers in the Netherlands with their sensitive teeth, colds and flu or joint pain. You will help people enjoy life to the full again.
In the bigger picture the purpose of Regulatory Affairs is getting quality products to the market with optimal claims and keeping them there, by knowing relevant legislation and complying/respecting to it.
You’ll do so by providing product-related regulatory information to other departments, authorities, consumers, health care professionals and trade associations.
The professional has responsibility for Regulatory Affairs in defined portfolios or activity streams within their markets/areas. This includes:
- Ensure products within scope (inc medicines, devices, cosmetics) can be placed on the market with optimal, yet compliant claims, advertising and promotion in line with commercial plans
- Ensure products are maintained and meet internal and external compliance requirements
- Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, marketing/sales within local commercial business, supply chain and quality etc.
- Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of our client with local regulators, trade associations and other key external regulatory bodies.
- Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges
- Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope
Key Responsibilities include
- Manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market
- Manage compliance within defined portfolio/activity streams
- To work closely together with Artwork department for timely approval of new artworks
- Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
- To work with medical and marketing for timely approval of promotional materials
- Proactively manage impact of regulatory changes within defined scope of responsibility on the business
- Maintain required regulatory compliance databases, systems and processes
- Bachelor degree in Life Science
- Minimum of 4 years of proven experience in Regulatory Affairs
- Fluent in Dutch and English (French is a benefit)
- Experience in the Pharmaceutical or FMCG / OTC sector (i.e. local business, OTC products)
- Knowledge of the Dutch market - Belgian market is a benefit (knowing relevant legislation a.o.)
- Analytical mind, good attention to detail and problem-solving skills within a structured process
- Good team player – working well in cross-functional teams
- Good communication skills
- Pro-active and open personality, no hesitation in asking questions
This assignment is open to freelancers or professionals who can look forward to a contract for six months at Yacht.
Good salary and benefits.
Working (partially) from home is an option.
Part time is possible as of 3 days, 4 or 5 days is also possible.
Our client is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. The Dutch office is located in the Utrecht area.
You will be part of a Benelux Regulatory team of six, of which two colleagues in the Netherlands.
ABOUT YACHT JOIN US Yacht leads the way in connecting professionals. We offer challenging projects and jobs with inspiring organizations such as Siemens, ASML and Philips. For you, joining Yacht will be the start of building a large and powerful network. A network made up of professionals just like you with whom you can share knowledge and experiences. ‘Together, we achieve more’ is our philosophy.
REAL GROWTH We believe that real growth happens in the workplace. That’s why we focus on offering you the opportunity to become involved in interesting and challenging projects. You will become a member of the Yacht network. And of course you will constantly be working on new challenges, so that you will keep your knowledge and skills up-to-date.
A DRIVING FORCE Yacht has been recruiting for the most innovative market leaders in the Netherlands for over ten years. During that time, we have been the driving force behind the careers of hundreds of professionals. Both our clients and our candidates value our in-depth knowledge of the skills needed to work in our client organizations every day.
WHAT DRIVES YOU? Our understanding of what it takes to be professionally successful is second to none. And so we know how vital it is to look beyond basic skills requirements and educational background. We look at the person underneath. In practical terms, this means that before introducing you to one of our clients, we will take into account the factors that motivate you, your preferences with respect to an organization’s mission and culture, and – of course – your own personal circumstances and interests.
A RANDSTAD COMPANY Yacht is a Randstad company. Randstad is a global leader in recruitment and human resource solutions. Founded in the Netherlands in 1960, we are now active in over 40 countries and we employ more than 29,000 people. We provide employment opportunities for 576,000 people every day. When you join Yacht, you can call on our extensive network of highly trained and experienced professionals.
Voor meer informatie neem je contact op met Reinier Heidemann via telefoonnummer 06-21517659
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.