Release Specialist At Sanofi |Pharmaceutical Sciences or other Medical Degree Vacancy
Managing the release process for imported products portfolio to ensure release activities are done at optimum time thus maintaining products supply versus the required demands.
Handling the release activities for free Medical samples, promotional materials (as needed).
KEY RESPONSIBILITIES AND DUTIES:
Preparation of MOH Inspection visits for imported products portfolio release including inspection dossiers preparation, NODCAR/NORCB dossiers preparation, reagents, reference standards management and related logistics.
Preparation & Submission for NORCB pre-evaluation for Biological products and follow up with the HAs until the issuance of the Pre-evaluation report.
Handle EDA inspection visits and analysis process at NODCAR / NORCB, ….etc.
Submission of samples for analysis & regular follow-up until the issuance of the conformity report & final release.
Tracking of the required documents supporting the release activities e.g CPPs and GMPs.
Archiving of all submission packages, HAs reports and communications.
Responsible to know, adhere to and advise others on regulatory authority regulations and guidance
Ensuring compliance of the release activities with all applicable laws, regulations and company procedures.
Secure and manage the process for reagents, reference standards & any other analysis requirements needed for batch release including timely orders, follow up until delivery & submission to the HAs.
Accountable for maintaining an accurate and up-to-date database in-terms of tracking.
Accountable for archiving of all documents related to all activities in scope activities.
Support the regulatory team for samples withdrawal for regulatory activities (New registrations, renewals, Variations) upon need.
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Responsible for applying the HSE related requirements for the company in all related working procedures.
Job holder requirements
Bachelor of Pharmaceutical Sciences or other Medical Degree
Experience of 2-4 years in the relevant field.
Good Command of English Language
Negotiation & Communication Skills.
Good planning and organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities
Ability to interact and communicate effectively and efficiently with other functional departments in the business and with Health Authorities
Play to Win Competencies :
Stretch to go beyond the level we have operated at up until now.
Take action instead of waiting to be told what to do.
Act in the interest of our patients & customers.
Put the interests of the organization ahead of my own or those of our team