Job title: Global Regulatory Strategic Platform

• Location São Paulo - Parque da Cidade - SP

About the job:

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That's why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.

Join us on our mission. Health. In your hands.

Our Team:

The Global Regulatory Strategic Platform (SRP) - Project Lead is responsible for managing of products portfolio under development and/or marketed products. For multi-regional products/projects the SRP Project Lead provides support to Global CHC Regulatory Categories (Innovation Science) as well as to the Lifecycle Management teams as appropriate for some operational aspects on dossiers preparation, submission and maintenance.

Main responsibilities:

• Co-development of the regulatory strategy and provision of regulatory expertise within project/product teams for products under development and/or marketed products across Regions in scope (as per INN assignment) with focus to also find the synergies across the Regions in scope;
• Ensuring timely execution of the GRPS milestones for the development projects as per Blue print;
• Defining, coordinating and contributing to the preparation of the dossiers and responses documents to Health Authority questions with the stakeholders (Non-clinical, clinical, Medical, Pharmacovigilance, etc.);
• Accountability for the maintenance of the existing CHC portfolio at the Regional level. As an interface between Science Innovation team/LCM team and countries will manage the preparation of ready to submit dossier for such activities as renewals, variations, benefit/risk assessments, referrals, discontinuation process, PRAC signals, PBRER/PSUSA/DSUR, etc;
• Ensuring compliance of regulatory activities for development and marketed products across Region;
• Ensuring business continuity with the packaging management for shared packs (Standard Export Pack - SEP) implementation;
• Coordinating Regulatory sub-teams within Science Hub and be the regulatory representative in outside GRA multi-function teams (in a e.g. strategic business reviews at Regional level, etc);
• Providing regulatory support for registration activities in countries outside of the Region in the spirit of Play to Win, searching for synchronization and synergies;
• Leading and coordinating scientific advices (including briefing package preparation), oral explanations , pre-submission meetings for Regional projects/products;
• Following regulatory changes, competitor's status and assessing potential impact on daily activities and project strategy;
• Ensuring regulatory database and regulatory requirements are updated timely;
• Contributing as needed to review the opportunities from Business Development;
• High level coordination of Marketing Authorization transfers across of Regions in scope
  (legal aspect, regulatory assessment, requirements and planning).

Individual contributors:

• Maintain knowledge of and comply with the principles of Ethics and Integrity, Sanofi policies and codes of conduct that regulate the pharmaceutical market;

• Comply with and promote Sanofi Health, Safety and Environment (HSE) policies, with the aim of preventing accidents, avoiding health risks, promoting employee well-being and reducing environmental impacts resulting from the execution of work activities;

• Support Sanofi Diversity & Inclusion strategy and initiatives to ensure all employees and partners are treated with respect and receive equal opportunities.

Managers:

• Promote the culture of Ethics and Business Integrity in your team by serving as a role model by ensuring appropriate knowledge and adherence to the principles of ethics and integrity, Sanofi policies and codes of conduct that regulate the pharmaceutical market;

• Comply with and promote Sanofi Health, Safety and Environment (HSE) policies in relation to the team it manages, which includes the Road Safety Program (Road Safety) with the purpose of preventing accidents, avoiding health risks, promoting the well-being of employees and reducing environmental impacts resulting from the execution of their work activities;

• Support Sanofi Diversity, Equity and Inclusion strategy and initiatives to ensure all employees and partners are treated with respect and receive equal opportunities.

About you:

• Experience: 3-5 year experience in the CHC or pharmaceutical industry, in Regulatory Affairs (global, regional or local).
• Soft skills: leadership, resilience, strategic influence, stakeholder management, positive. Good relationship ability; Adaptation capabilities; Ability to think strategically and strive for results; Ability to make decisions; Ability to resolve issues and proactivity.
• Technical skills: Strong knowledge and operational expertise of Regional regulations, Ability to produce written and oral regulatory or scientific communications with clarity, accuracy, rigor and assertively, Ability to communicate effectively and efficiently with other functional departments in the business, Dealing with complex project involving multiple functions and resources.
• Education: Physician, Pharmacist, Veterinarian or Life Sciences Degree.
• Languages: Fluent in English, Spanish, Portuguese

Pursue progress, discover extraordinary:

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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