Senior Regulatory Affairs Specialist

Primary Function of Position

This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets.

Essential Job Duties

• Lead global regulatory submissions for product registrations and variations.
• Develop regulatory strategies for new product development and market entry.
• Advise cross-functional teams on global compliance requirements.
• Oversee preparation of technical files and documentation for audits.
• Manage agency communications for complex product approvals.
• Provide expert guidance in interpretation of international regulations.
• Review, approve, and update regulatory labeling and documentation.
• Mentor and coach regulatory affairs specialists.
• Track and report metrics on regulatory timelines and success rates.
• Represent regulatory affairs team in project meetings.

Qualifications

• Minimum 8 years of experience in regulatory affairs.
• Bachelor’s degree in a relevant discipline, or equivalent combination of education and experience.