Regulatory Affairs Officer

il y a 2 semaines

Gent, Belgique Cooper Consumer Health Temps plein

Requisition ID
- 39
- Job Family 1- Regulatory & PSRM
- Country 1- Belgium
- Location 1- Hybrid
- About us
- **Cooper Consumer Health** is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) products with strong brands such as Valdispert, Oenobiol, Excilor, Vitascorbol, Lashyle and many more.

With a presence in seven countries, we supply more than 80,000 independent pharmacists, e-commerce players, wholesalers, drugstores, and hospitals, generating around €600m in revenue.

Headquartered in Paris and with almost 1,000 employees, we take an entrepreneurial approach with strong local accountability. Our ‘global-local’ culture and bias towards action allow us to operate with agility and speed.

At **Cooper Consumer Health**, we are driven by our mission to help people improve their own health and wellbeing using effective selfcare solutions. We rely on our talented employees to achieve this, empowering them to take ownership of their work, think outside the box and challenge the status quo to drive innovation. We value a culture of respect, transparency, and inclusivity, where everyone is treated with dignity and fairness.
- Job description 1
- **JOB DESCRIPTION**

The local Regulatory Affairs Officer ensures local regulatory compliance of all products (medicines, cosmetics, food supplements, medical devices, biocides,..): authorisations, notifications, local compliance artwork and advertising,...
The local Regulatory Affairs officer acts as local contact person between the global regulatory team and the local regulatory authority, ensuring that products are manufactured, marketed and distributed in compliance with appropriate legislation.
The local Regulatory Affairs officers acts as a local contact person for vigilance for the global vigilance team ensuring that all vigilance complaints are transferred to the global vigilance team in a timely manner and consumers are contacted and informed.

**RESPONSABILITIES**
- Supports the global regulatory team to ensure local regulatory compliance of global brands: authorisations, notifications, local compliance artwork and advertising
- Is end responsible for regulatory compliance of local brands: authorisation, notifications, compliance artwork and advertising.
- maintains a good relationship with the local authorities and develops in-depth knowledge of local regulations and requirements.
- Keeps up with local regulations, informs global regulatory, and initiates implementation of relevant changes.
- Is local contact person for vigilance and responsible for translation, timely transfer of the cases to the global vigilance team. He/She supports the global vigilance team and is in contact with the consumer in case more information is needed to further evaluate vigilance cases.
- Is responsible for local regulatory and vigilance training.
- Is responsible for answering medical questions (internal and external)

Maintain close relationships with local commercial and market access functions.

**EXPERIENCE PROFILE**
- Scientific background is a must - master’s degree in pharmaceutics, health care, life sciences or related fields.
- 3 to 5 years of experience in a similar role, preferably in an international environment.
- Regulatory experience with medicinal and non-medicinal products such as food supplements, medical devices and cosmetics.
- Excellent planning and time management skills
- A good knowledge of relevant European and national guidelines, applicable legislation and regulations
- Fluent communication skills in Dutch, French and English (written and oral) -To adapt according to the country.
- Personality: determined, persuasive, assertive, and communicative.

**COMPETENCIES**
- Strong team player, with the ability to work effectively in team setting and interaction with people of different seniority and functional backgrounds.
- Ability to work independently and as part of a team
- Ability to handle and enjoying complex and changing environments.
- Accurate and decisive
- Solution oriented
- Ability to transfer knowledge.
- Ability to consistently meet deadlines, remain organized, adaptable and autonomous.
- Good communication and presentation skills
- Good English language skills (spoken and written).
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Eagerness to learn & grow

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