Regulatory associate Morocco
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 products according to regulatory requirements and Sanofi policies.
In alignment with the regulatory country / MCO/ Zone Head represents the Business Unit at the Regulatory Health Agency of the countries under his responsibility.
Ensure regulatory environment and requirements are well understood and considered in product business strategies.
Main Responsibilities and Activities:
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 liases with pertinent Sanofi functions to ensure implementation of new ways of working as per need.
Work to ensure “one Sanofi” position in front of country HA, aligning priorities between the different GBUs and the regulatory country head/lead
Participate and contribute to the definition and implementation of strategies to prepare external regulatory environment to accommodate innovation
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
Ensure, in alignment with country/MCO head, execution at local level of regulatory strategy to maximize attendance of commercial strategies (GRA Blue Print principle)
Collaborate with other GRA function to ensure dossiers submitted to HA are maintained and updated in line with current regulatory standards and legal requirements
Manage portfolio rationalization activities, aligning GRA objectives with affiliate objectives
Work to assure Sanofi teams globally are well knowledgeable on country HA requirements (trainings and database updates)
Manage 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 team
Ensure team acts in compliance with companies directives and policies
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
DATE POSTED
05/27/2022
CONTRACT TYPE
Full time
JOB ID
R2649010
LOCATION
Casablanca, Morocco
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 products according to regulatory requirements and Sanofi policies.
In alignment with the regulatory country / MCO/ Zone Head represents the Business Unit at the Regulatory Health Agency of the countries under his responsibility.
Ensure regulatory environment and requirements are well understood and considered in product business strategies.
Main Responsibilities and Activities:
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 liases with pertinent Sanofi functions to ensure implementation of new ways of working as per need.
Work to ensure “one Sanofi” position in front of country HA, aligning priorities between the different GBUs and the regulatory country head/lead
Participate and contribute to the definition and implementation of strategies to prepare external regulatory environment to accommodate innovation
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
Ensure, in alignment with country/MCO head, execution at local level of regulatory strategy to maximize attendance of commercial strategies (GRA Blue Print principle)
Collaborate with other GRA function to ensure dossiers submitted to HA are maintained and updated in line with current regulatory standards and legal requirements
Manage portfolio rationalization activities, aligning GRA objectives with affiliate objectives
Work to assure Sanofi teams globally are well knowledgeable on country HA requirements (trainings and database updates)
Manage 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 team
Ensure team acts in compliance with companies directives and policies
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
DATE POSTED
05/27/2022
CONTRACT TYPE
Full time
JOB ID
R2649010
LOCATION
Casablanca, Morocco