CHC Regulatory specialist
Sanofi -
Cairo, EgyptPosted 4 years ago42People have clicked1 open position
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Job Description
Job Purpose:
To manage & monitor the Consumer Health Regulatory activity (renewal, variation, new launches,pricing, promotion materials).
KEY RESPONSIBILITIES AND DUTIES:
- Interface with various project/product teams.
- Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
- Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
- Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate.
- Manage the maintenance of a portfolio of products.
- Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
- Provide support and communicating information on products to other functions (submissions, approvals, etc.).
- Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
- In liaison with his/her manager, can be involved in activities such as shortages, DHPC (in collaboration with Pharmacovigilance department), B/R reevaluation, etc.
- Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
- Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
- Plan for preparation / review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
- Plan for preparation / review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines.
- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
- Maintain the products labeling up to date, implementing global and local labeling decisions , through labeling preparation, review and approval
- Updating the internal Sanofi Systems regularly
- Carrying the planned LCM activities and reflecting the approvals on the internal systems
- Preparation, submission and follow up of pricing files internally and externally
- Assure compliance with IA files
- Following and complying with all the defined internal policies and procedures of working
- Following strictly all the Authority Regulations, decisions & decrees
- Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
Job Requirements
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS :
- Education Level: bachelor's pharmacy, science or vet.
- Experience: Minimum of 2-4 years experiences in Regulatory Affairs field (Consumer Health experience will be an asset) .
Skills :
- Project management experience in the pharmaceutical industry or in a regulatory environment.
- Knowledge in regulatory requirements and Good Manufacturing practices of the cluster
- Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
- Ability to work with multi-functional and multicultural teams
- Ability to act as a Business Partner and customer oriented
- Ability to communicate effectively and efficiently with other functional departments in the business
- Good relationship ability
- Good 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
- Language requirements: Fluent in English
COMPETENCY REQUIREMENTS :
- Act for Change
- Strive for results
- Cooperate Transversally
- Commit to Customer
