Regulatory Affairs Specialist
il y a 5 jours
To strengthen our expertise, we are currently looking to hire a **Regulatory affairs specialist**
As Regulatory Affairs specialist, you will ensure that pharmaceuticals and medical products meet legislative requirements.
Are you an analytical and detail-oriented person with knowledgeable in pharmaceutical and medical legislations?
Do you have excellent communication skills and organizational skills and ability to respect deadlines ?
**Your responsibilities**:
- Coordinate and interact with the internal stakeholders for the preparation of the documents part of the **regulatory dossiers/data-packages**
- Ensure that all regulatory aspects on the **product safety/Pharmacovigilance** and commitments/obligations to Authorities are closely monitored and fulfilled
- Stay up to date with changes in r**egulatory legislation** and **guidelines **and communicate these information to internal stakeholders
- Offer advice about **company policies, practices** and systems to manufacturers/scientists
- Identify key issues on registration activities that could prevent achieving objectives and pro-actively propose solutions
- Maintain close contacts with the Local Operating Companies **(LOC’s)** to ensure shared objectives are achieved
- Liaise and negotiate with regulatory authorities
- Write comprehensible, user-friendly, clear product information leaflets and labels
**Qualifications**:
- Master Degree in Pharmacy, Chemistry, Biology or related fields
- A minimum of 2 years Regulatory affairs experience or in a related area in Healthcare industry
- You have knowledge **of Regulatory legislation** in at least one geographic area
- Excellent planning skills & attention to details
- Strong multitasking skills & operate in a fast-paced environment
- You can work to ensure deadlines
- You have integrity and analytical capacity
- You have good collaboration skills, you are able to work with different teams
- You are customer oriented
- IT skills : you know how to us Microsoft office et databases
- You are fluent in **French** and have an advanced level in **English** (written and spoken)
Type d'emploi : Temps plein, CDI
Avantages:
- Aide au développement professionnel
- Assurance groupe
- Assurance hospitalisation
- Carte essence
- Chèques repas
- Eco-chèques
- GSM de fonction
- Horaires flexibles
- Jours de congés supplémentaires
- Ordinateur de fonction
- Télétravail
- Voiture de société
Horaires:
- Lun-Ven
- Travail de jour
Rémunération supplémentaire:
- 13ème mois
- Pécule de vacances
Formation:
- Master (Exigé)
Langue:
- Français (Exigé)
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