- Secteur d'activité
- Services
- Date de création
- Il y a 4 semaines
- Nombre de postes
- 1
- Niveau de poste
- Responsable d'équipe
- Type de contrat
- CDI
Description:
Halkorb RH seeks on behalf of its customer, a multinational pharmaceutical company, a Regulatory Affairs Pharmacicst / Manager
Missions du poste :
Missions du poste :
- Ensure preparation and submission to Competent authorities (CA) of Marketing authorization applications, renewals and variations…etc in compliance with the regulatory requirements (content and format), in the targeted timelines and assure an active follow-up for a timely approval
- Follow-up of local implementation of variations when applicable
- Be a regular contact point for CA (ANPP, MoPI, MoH, CNPM…etc)
- Provide proactive regulatory opinion and advice whenever the occasion demands it, to contribute to the regulatory strategy in collaboration with the other concerned departments and direction
- Prepare all requested documents and follow up of importation programs in collaboration with local partners
- Ensure in collaboration with local subcontractors and global departments, preparation, revision and validation of artworks
- Follow up of finished products batches release when necessary
- Participate to the local organization of Pharmaceutical Responsibility, its implementation and maintenance including writing and implementation of local procedures, training of the concerned personnel…etc
- Management of complaints and batch recalls if needed
- Ensure compliance with local and global requirements regarding validation and declaration of promotional activities
- Ensure compliance with global requirements regarding the management of local medical information
- Ensure the use and the update of relevant the company databases
- Participate to the preparation, reviewing and submitting to the global department and to competent authorities of PV cases and concerned parts of periodic safety reports
- Setting up and/or update local procedures.
- Diploma in Pharmacy
- At least 4 years experience in regulatory affairs; experience in market access would be a big plus
- Experience in managing Pharmacovigilance processes would be a plus
- Communication skills and good command of English & French (verbal & written)
- Knowledge of current regulations and the organizational structures of the various pharmaceutical sector institutions in Algeria (MIPP, ANPP, MTESS, MSPRH, PCH).
- Experience in the preparation, submission and follow-up of applications for registration decisions, renewal applications and variation applications to the relevant authorities
- Experience in managing Pharmacovigilance processes would be a plus
- Good listening skills and ability to receive constructive feedback
- Ability to collaborate effectively with colleagues and contribute positively to a harmonious working environment
- Ability to organize and manage time effectively to maximize productivity
- Adherence to high ethical standards, honesty and transparency in all professional interaction.