- Postes vacants:
- 1 poste ouvert
- Type d'emploi désiré :
- Intérim
- Experience :
- 3 à 5 ans
- Niveau d'étude :
- Maîtrise, IEP, IUP, Bac + 4
- Langue :
- Français, Anglais
Description de l'emploi
Crit recrute pour le compte de son client pour une mission de 9 mois un Regulatory Affairs Project Coordinator :
Mission:
- Manage Regulatory Affairs activities.
Advance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals as appropriate
Work closely with supply department to ensure robust strategic approaches continuity of supply to the patients
Manage any Health inspection notification process regarding upcoming events related to Tunisia portfolio.
Coordinate labelling activities for products in Tunisia (artwork development, liaison with labelling centers, database management)
Provide Launch Excellence Tool support as applicable.
Market access understanding: Assist in management of product pricing for products in Tunisia
Notify immediately of awareness of any regulatory requests, including safety labelling changes, urgent safety restriction requests, as well as external inspections.
Keep abreast of emerging legislation and highlight the potential impact on the business.
Escalates any relevant information to the regulatory specialist Tunisia & regulatory NWA lead, providing leadership
Ensures compliance within the regulatory department and collaborates with pharmacovigilance and other stakeholders, as appropriate, to ensure compliance with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives .
Patient centricity: Supports the best interests of patients, the Affiliate within the country with regards to the interactions with the Health Authorities and any other regulatory authorities
Establish and maintain good relationships with all involved regulatory institutions in Tunisia through leveraging on the strong partnership with the external partner.
– Regulatory intelligence: identify and track changes/trends in the authorization practice and attitudes in Tunisia and communicate them within the Company.
Exigences de l'emploi
Skills & Behaviors:
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· Team player with the ability to work cross-functionally
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- Regulatory expertise:
- Significant knowledge of Local Regulatory Affairs requirements.
Education:
– University degree and experience in regulatory affairs
– Education: University degree in Doctor of Pharmacy
Date d'expiration
20/06/2020