- 14 december 2017
- vacaturenummer: 9048236
Yacht Life Sciences has a vacancy for a Regulatory Affairs Manager Benelux.
As a Regulatory Affairs Manager your will:
- Manage a defined portfolio of products within the Benelux Regulatory Affairs Group to ensure proactive and timely compliance with all European legislation and ensure that all regulatory activity is planned and geared to support and deliver commercial requirements.
- Identify and communicate regulatory issues which have the potential to affect the competitive impact of Consumer Healthcare products in Benelux.
- Provide an effective regulatory service to allow OTC medicines, medical devices and cosmetic products to be legally sold with strong claims which can be supported.
- Ensure all regulatory maintenance activity, pack copy and advertising for the business is managed to comply with the regulations and relevant company requirements.
- Responsible for ensuring that medicinal, medical device and cosmetic products can be legally sold and supported in compliance with regulations.
- Provide advice, recommendations and support for product claims, copy and labeling.
- Responsible for ensuring that all personnel are given adequate training and guidance in all aspects of regulatory affairs work, and to ensure that all regulatory systems and databases are up to date and effectively managed.
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines. Responsible for the maintenance activities associated with a defined portfolio, including product renewals, and routine PV activity.
- Sets and resets priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives.
- Creates and maintains good working relationships within the Brand Marketing teams, as well as other key functions, including factories and GMS teams, Quality, R&D, and with influential external bodies (Trade Associations, professional bodies, academia).
- Leadership of, preparation and review of day to day submissions with full accountability for delivery. May also take accountability for larger projects as part of a broader project plan i.e. line extensions, global strategic projects, system changes etc.
- Contribute to the assessment of new innovation projects and exploratory product development briefs.
- Working with Category Regulatory Representatives, help develop the regulatory strategy or components of filing strategies designed to minimize time for development and regulatory approval and optimize competitive positioning and global opportunities.
- Required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities and lead regulatory interactions.
- Identifies, challenges, develops and implements written procedures (e.g. local SOPs, work instructions), and proactively highlights opportunities for process improvement.
- Responsible for highlighting own training needs and working with his/ her manager to develop a training plan and achieve training goals.
- Bachelor/Master degree in bio-pharmaceutical or bio-medical sciences (or comparable study)
- >5 years experience in Regulatory Affairs within the Pharmaceutical or Consumer Healthcare industry, and of which 2 years in a similar position
- A fluency in both Dutch and English
- Coaching/ leadership skills
- Proactive, result oriented, and team player
- Excellent communication and advisory skills
We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up to date: boosting your career through personal and scientific growth.
Our client focuses on the marketing and sales of oral care, personal health care and freely available drugs. This company belongs to the most important companies in the world in the area of self-care and is the second largest in the field of oral care
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
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.
Deze vacature wordt via YACHT aangeboden. Het solliciteren en verdere contact verloopt via YACHT.