Lead strategic initiatives to ensure regulatory compliance while driving business growth
Develop and implement regulatory strategies, mentor teams, and manage critical relationships with regulatory agencies worldwide
Oversee regulatory compliance activities and provide expert guidance on regulatory requirements
Ensure successful product submissions across various jurisdictions
Shape regulatory strategy for product development, manufacturing, and commercialization while maintaining high standards of compliance
Influence global regulatory policy and drive innovation in regulatory approaches

Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operations
Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines
Successful track record of regulatory submissions and agency interactions
Leadership experience managing and mentoring multi-site teams
Experience in regulatory strategy development and implementation
Demonstrated expertise in regulatory compliance and quality management systems
Advanced project management and organizational skills
Excellent verbal and written communication abilities
Effective negotiation and influencing skills
Ability to work effectively in a matrix organization
Business acumen and strategic thinking capabilities
Proficiency in standard office technology and regulatory systems
Fluency in English required; additional language skills advantageous
Ability to travel 25-50% of time, primarily international
Experience with CDMO/pharmaceutical services preferred
Knowledge of current industry trends and participation in professional associations (e.g., TOPRA, PDA)

Director, RA OSD/API

Key skills