Senior Regulatory Affairs Specialist

Job description

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 and bachelor’s degree in a relevant discipline, or equivalent combination of education and experience. Required Knowledge, Skills and Abilities

• Expertise in global regulatory requirements and registration processes.
• Advanced project leadership and communication skills.
• Technical documentation review and approval capabilities.
• Agency negotiation and strategic planning proficiency.
• Experience with audits, submissions, and training.

Physical Requirements

• Not applicable