At Sanofi CHC, we have one shared purpose - we work passionately, every day, to 'serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people - our consumers, our customers, healthcare professionals, and our employees - across the world.
We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Consumer Healthcare company. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.
As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect and integrity.
SANOFI CHC is currently looking for Regulatory Affairs Lead.
Accountable for Sanofi CHC regulatory activities related to products 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/her responsibility.
Ensures regulatory environment and requirements are well understood and considered in product business strategies.
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 Scientific Affairs 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 Sanofi CHC position in front of country HA, aligning priorities among the different departments and the scientific affairs head
As per need and upon delegation of the scientific affairs head, 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 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
Ensures, in alignment with scientific affairs head, execution at local level of regulatory strategy to maximize attendance of commercial strategies
Collaborates with other GRA function 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 CHC: 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 regulatory risk assessment and management.
Ensure Regulatory support for product crisis (shortages, discontinuation, counterfeit, recalls)
Manage BU/TA budget following company processes and in alignment with country / MCO Head
Acts in compliance with company directives and policies
Must be bachelor's degree holder
Has at least 10 years experience in Regulatory and at least 5 years in management position, preferably from the pharmaceutical and FMCG industries.
Excellent English communication in oral and written
Do you think you have what it takes to be Regulatory Affairs Lead? Then, click APPLY now and we will be happy to assist you.
NOTE: Please inform your line manager of your interest to apply
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.
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