Lead - Regulatory Affairs

Coordinate with cross-functional teams to implement regulatory initiatives and quality improvement projects.

Manage the entire gamut of regulatory activities for affiliate which includes Vaccines, Biologicals, Pharma, bulk drugs and manufacturing sites with CDSCO.

Involved in securing time bound approvals and completing time bound submissions for all projects of the company

• Communication Facilitation: Act as the primary point of contact between organization and relevant health authorities. Facilitate clear and effective communication channels to ensure timely dissemination of information, updates, and directives.
• Collaboration and Coordination: Collaborate with internal departments such as regulatory affairs, legal, compliance, quality assurance, and clinical operations to ensure alignment with regulatory requirements.

Work with IP commission, NIB, CDTL or any other government laboratory for company projects and products

• Regulatory Compliance: Stay abreast of local, state/provincial, and national healthcare regulations, guidelines, and policies. Ensure that the healthcare organization complies with all applicable laws and regulations, and assist in developing strategies for compliance.

Custodian and facilitate exchange of sensitive and confidential information with Health Authorities

• Advocacy and Representation: Advocate for the needs and interests of the organization to health authorities. Represent the organization in meetings, hearings, and other forums to present perspectives, address concerns, and negotiate on regulatory matters.

Build equity and trust of Sanofi with Health Authorities

Be the face/single point of contact for Sanofi with the Health Authorities.

• Relationship Building: Build and maintain positive relationships with key stakeholders, including health authorities, government officials, industry associations, and advocacy groups. Collaborate with external partners to advance shared goals and initiatives in public health.

• Policy Analysis and Development: Support analysis of proposed healthcare policies, legislation, and regulatory changes.

Provide insights and recommendations to internal stakeholders regarding potential impacts on the organization and develop strategies for proactive engagement with health authorities.

• Risk Management: Identify potential compliance risks and develop mitigation strategies. Conduct internal audits and assessments to evaluate adherence to regulatory requirements and recommend corrective actions as needed.

• Data Analysis and Reporting: Collect, analyze, and report data related to regulatory compliance, quality metrics, and performance indicators. Support preparation of reports and presentations for senior management, regulatory agencies, and other stakeholders.

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, ability or gender identity.

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