Regulatory Affairs Lead, Project Manager

About the Role

We are looking for a Regulatory Affairs Lead/ Project Manager

Key Responsibilities

• Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
• Plan and Prepare Regulatory Project Plans/Submission Strategies
• Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
• Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
• Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
• Act as the primary point of contact for clients, ensuring proactive and effective communication.
• Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
• Collaborate with business development teams to support proposals and regulatory strategy discussions.
• Mentor and guide junior team members, fostering a culture of excellence and accountability.

Qualifications

• 4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
• Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
• Proven track record of preparing and submitting applications to regional/global Health Authorities.
• Strong client-facing and stakeholder management skills.
• Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
• Excellent organizational, communication, and leadership skills.

Why Join Us

• Opportunity to work on diverse global projects across multiple markets.
• Collaborative, growth-oriented, and innovative work culture.
• A platform to take ownership, lead client interactions, and contribute to global healthcare access.