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. • Minimum 8 years 6–8 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