Senior Manager, Regulatory Affairs

The Senior Manager, Regulatory Affairs, EU & ROW will manage assigned regulatory affairs activities through preclinical and clinical development.

Key Responsibilities

• Ensures timely planning, coordination, submission and approval of clinical trial applications, PIPs, scientific advice briefing books, marketing applications, etc.
• Interact with regulatory agencies and develop and maintain strong relationships with competent authorities both remotely and face to face.
• Responsible for submitting high quality regulatory documents required to obtain successful outcomes.
• Manage activities required to meet regulatory requirements, global guidelines and other required procedures within assigned projects.
• Own and manage document development and submission such as IMPDs, scientific advice briefing books etc.
• Act as EU/ROW regulatory representative on clinical study teams and translate regulatory requirements for project team members.
• File and track of regulatory activities for assigned projects, and maintain internal processes to ensure compliance.
• Provide support to cross functional project team members on Regulatory matters impacting the project.

Qualifications

• Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines.
• Bachelor’s degree in Regulatory Affairs, Life Sciences, or a related discipline required, Master’s degree preferred.
• 5+ years of experience in regulatory affairs within pharmaceuticals, biotechnology, or medical devices.
• Minimum 3 years of managerial or team lead experience.
• Demonstrated success managing regulatory submissions and product approvals.

Preferred Skills & Experience

• Deep knowledge of U.S., EU, and international regulatory frameworks (FDA, EMA, ISO, MDD/MDR, GxP).
• Strong project management and organizational skills with ability to drive complex submission timelines.
• Excellent written and verbal communication; strong ability to negotiate with regulatory agencies.
• Analytical problem solving skills with proven ability to assess regulatory risks and impact.
• Cross functional leadership and influence across diverse teams.

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