CHC Regulatory specialist - Sanofi

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.
• Ensure the management of the artworks Use of the Vista & VistaVac tools for the management of the artworks
  • Download the dossiers to Vista & VistaVac tools
  • Use veeva vault & RT
• Ensure update the databases (Veeva Vault)
  • Update the regulatory events in databases (Veeva Vault)
  • Monitor the regulatory events in databases (Veeva Vault)
• Ensure the administrative documents related with PoA, CPP, GMP
  • Prepare the administrative documents related with PoA, CPP,GMP by using mail, legalization, translation requests, posting and archiving in the countries concerned and exportation if applicable.
•  Ensure all documents are  translated in compliant with Health Authority requirements
  • Know the Health Authority requirements
  • Ensure all documents are translated in compliant with Health Authority requirements
• Ensure regulatory compliance with products and country requirements
  • Ensure regulatory compliance with products overall strategies
  • Ensure regulatory compliance with Health authorities country requirements evolution

Others:

• 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

KEY WORKING RELATIONSHIPS INTERNAL

Cross Functional Collaboration with:

• COE Cluster Heads
• Regional/Affiliate RA Heads
• Regional/Affiliate Managers
• Regional/Affiliate Associates
• CMC&Medical devices department
• Labeling department
• RSOs
• Regulatory Excellence teams

Occasional Contact with:

• Supply chain
• Business units

EXTERNAL

Would be expected to be involved with:

• Vendors/service provider

• Manufacturer associations

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

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