Overview
Rare Diseases/Immunology Regulatory Lead Jobs in Midrand, South Africa at Sanofi
Rare Diseases/Immunology Regulatory Lead
Apply locations Midrand time type Full time posted on Posted 3 Days Ago time left to apply End Date:
January 31, 2025 (3 days left to apply) job requisition R2783171
ABOUT THE JOB:
JOBPURPOSE:
Accountable to ensure that regulatory activity is submitted and approved in due time.
Develop relations with key regulatory authorities at a country level; discuss issues and find solutions in the best interests of company.
In alignment with Country Head and other BU/TA heads in the country, analyses and communicates any changes in the regulatory area and liaises with pertinent Sanofi functions to ensure implementation of new ways of working as per need.
Works to ensure “one Sanofi” position in front of country HA, aligning priorities between the different GBUs and the regulatory country head/lead.
As per need and upon delegation of the country head/lead be Sanofi´s representative in pharma chambers / associations and ensure representation of company in HA working groups / public consultations.
Participates and contributes to the definition and implementation of strategies to prepare external regulatory environment to accommodateinnovation.
Provide regulatory expertise within the specific GBU / TA commercial teams, ensuring total compliance with legal requirements and ethical norms.
Focal point for Regional / global regulatory product, COE or CMC leaders to discuss strategies for registration, submission and approval of new MA´s and variations in the country.
Ensures, in alignment with country/MCO head, execution at local level of regulatory strategy to maximize attendance of commercial strategies (GRA Blue Print principle).
Collaborates with other GRA functions to ensure dossiers submitted to HA are maintained and updated in line with current regulatory standards and legal requirements.
Manages portfolio rationalization activities, aligning GRA objectives with affiliate objectives.
Works to assure Sanofi teams globally are well knowledgeable on country HA requirements (trainings and database updates).
Manages team to support business needs within the different GBUs:
Promo and non-promo material approval, product strategies (new products and LCM) discussion and implementation, regulatory input – trends and competitors intelligence – in Brand teams.
Be responsible for regulatoryrisk assessmentand management.
Ensure Regulatory support for product crisis (shortages, discontinuation, counterfeit, recalls).
Controls all activities of the team reporting to him, ensuring that staff is qualified and competent, properly coached, given the opportunity to develop in the company and enable them to handle the demands of their jobs and achieve their objectives.
Manage BU/TA budget following company processes and in alignment with country / MCO Head.
Ensure team acts in compliance with company’s directives and policies.
KEY ACCOUNTABILITIES:
Accountable for all Sanofi regulatory activities related to products assigned to a specific Business Unit and/or Therapeutic Area in a country or multi-country / Zone organization.
Ensures the implementation of regulatory strategies and projects to obtain marketing authorization for new products and existing portfolio, having as ultimate goal regulatory compliant products to be commercialized according to business strategy.
Responsible to interact with all the appropriate stakeholders to ensure compliance of the prod…
Title: Rare Diseases/Immunology Regulatory Lead
Company: Sanofi
Location: Midrand, South Africa
Category: Healthcare, Management
