Regulatory Affairs Manager

Role Overview

The Senior Manager, Regulatory Affairs US leads the development and execution of regulatory strategies for assigned products, ensuring successful registration and lifecycle management for rare disease therapies. This role involves providing strategic regulatory guidance, managing submissions such as INDs and BLAs, and representing the organization in interactions with the US FDA and other external partners. The position requires overseeing operational activities related to regulatory authorizations, supporting global regulatory initiatives, and maintaining compliance with current regulations and emerging trends. Collaboration with cross-functional teams (Commercial, Medical, Global Regulatory) is essential to align regulatory strategies with business objectives.

Responsibilities

• Develop and implement US regulatory strategies for assigned projects/products.
• Manage regulatory submissions and communicate with regulatory authorities.
• Represent the organization in FDA meetings and external partnerships.
• Ensure compliance with regulatory requirements and oversee operational activities.
• Support governance activities, process development, and inspection readiness.
• Provide regulatory input across cross-functional teams for project deliverables.
• Stay current on regulatory requirements and trends within the jurisdiction.
• Demonstrate leadership, ethics, and effective communication with internal and external stakeholders.

Qualifications & Skills

• 6+ years of relevant regulatory experience in the pharmaceutical industry, with US regulatory expertise.
• Bachelor’s degree in life sciences; postgraduate degrees preferred.
• Proven ability to lead multiple projects and collaborate across global teams.
• Strong communication, judgment, and knowledge of GxP and regulatory guidance.
• Proficiency in Microsoft Office, regulatory systems (e.g., Veeva), and English; additional languages are a plus.

Why Choose This Role

Opportunity to work on innovative therapies for rare diseases, with a focus on patient impact, scientific advancement, and professional growth within a collaborative, purpose-driven environment.