Job Description

Job title: Lead - External Regulatory Affairs

• Location: Mumbai
• Job type: Permanent

About the jobAt Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing Health in Your Hands.We are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World.Consumers at the heart of everything we do and we want to make a difference where it counts, driving leadership in the categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu.To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world .

• Provide Strategic direction and management of Regulatory Affairs Function to provide regulatory services and initiatives in support of Sanofi India CHC Business objectives.
• Provide representation for Regulatory matters driving internal and external Stakeholder management, advocacy and representing company in Industry forums.
• Have a deep understanding of the regulatory eco-system for CHC business in India advising the company in regulatory topics.
• Build and represent Sanofi CHC externally with key government and industry stakeholders.
• Provide regulatory expertise at cross functional project team meetings.
• Ability to build strong internal networks and position self as expert with cross functional peers.
• Be recognized by local and global business areas as an innovative solution provider and partner for regulatory issues and risks.
• Strong ability to drive and connecting with Indian Health authority officers at DCGI.
• Responsibility of regulatory file submissions, comply with Indias regulations and internal processes.
• Provide company with the assessment of impact of new and changing regulations in India and Global regulatory environments on the local business including potential risks and mitigation strategies.
• Review and recommend policies, objectives and plans related to product under development to ensure it will fulfill the needs of regulatory authorities and thereby assuring prompt approval and launch.
• Develop regulatory standards and standard operating procedures.
• Ensure all licenses and regulatory compliance topics are properly monitored and up to date to enable smooth operations in the country.

Experience:

• Appropriate basic graduation (e.g degree in Pharmacy or other Life Sciences)
• Post graduate degree in pharmacy/life science preferred
• Minimum 10 years of work experience working directly or collaborating with policy makers and regulatory authorities in India.
• A deep understanding of policy and regulatory landscape and processes in India.
• Exposure to local regulatory environment and capability to adapt the regulatory organization and implement appropriate plans.
• Ability to collaborate with multiple internal and external stakeholders, as well as adapt to working in a fast-paced environment with local teams.
• Excellent written and verbal communication skills, Fluency in English
• Willingness to travel (approx. 20% of working time to Delhi)

Soft skills:

• Ability to think strategically and communicate clearly
• Strong understanding of local regulatory practice and decision making
• In-depth knowledge of regulations, policies.
• Computer proficiency in Microsoft Office and ability to develop and deliver audience -appropriate presentations to internal and external customers.
• Strong critical thinking and analytical skills.
• Project management
• Leadership
• Take accountability
• Science oriented
• Highly adapted to changing environment
• Skillfully plans
• Prioritizes, and executes multiple responsibilities and projects

Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnt 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, lets be those people.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.Watch our and check out our Diversity Equity and Inclusion actions atPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnt 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, lets 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, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

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