Manager Regulatory Affairs Role at Cepheid in Gurugram, Apply Now!
Looking to make a real impact in healthcare through regulatory leadership? Cepheid, a Danaher company, is hiring a Manager of Regulatory Affairs in Gurugram, India. This on-site role offers the opportunity to lead regulatory strategy, oversee submissions, and mentor a growing team in a fast-paced molecular diagnostics environment. Ideal for professionals with a PharmD and hands-on experience in global regulatory standards, this role supports life-saving innovations every step of the way.
At Cepheid, a leading Danaher operating company, we are committed to transforming healthcare through innovative, accurate, and scalable diagnostic solutions. Every test we develop is backed by a mission to improve patient outcomes, and every team member contributes to something greater — delivering critical diagnostics that touch lives across the world.
As a Manager of Regulatory Affairs, you will lead regulatory operations across India and neighboring regulated markets, playing a pivotal role in regulatory strategy, submissions, licensing, audits, and market access.
Location: Gurugram, Haryana, India
Category: Quality & Regulatory Affairs
Job ID: R1287461
Responsibilities:
- Guide team in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals as Regulatory Affairs.
- Mentor and coach team on complex regulatory business initiatives.
- Manage and translate strategy/plan into goals by building repeatable processes that help manage the team’s sustained delivery on performance metrics.
Minimum Requirements:
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PharmD degree with 7+ years of regulatory experience
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2+ years in a people management role preferred for Regulatory Affairs.
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Demonstrated success in regulatory submissions and authority interactions (e.g., CDSCO)
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In-depth knowledge of:
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ISO 13485
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US FDA 21 CFR Part 820
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Global quality systems and regulatory standards
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Excellent written and verbal communication skills as Regulatory Affairs
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Comfortable working in dynamic, matrixed environments
Highly Preferred:
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4+ years of experience leading teams
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Technical experience in IVD (In Vitro Diagnostics) or medical devices
Keywords: Manager Regulatory Affairs, Danaher job posting, Regulatory Affairs role, Regulatory strategy, Global Market Expansion
