Regulatory Affairs Lead, Project Manager

About the Role

We are looking for a Regulatory Affairs Lead / Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.

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.