Senior Regulatory Affairs Specialist
Core
Lead global regulatory strategies for pharmaceutical products, ensuring compliance with national and international regulations to bring therapies to market.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory submissions (NDAs) and post-market compliance activities for pharmaceutical products
Domain
Pharmaceuticals / Life Sciences
Required skills
Drug development lifecycle expertise, regulatory submission processes, ICH guidelines knowledge, GCP knowledge, GMP knowledge, strategic thinking, project management
Preferred skills
Mentoring junior staff, developing departmental processes
Technologies
SAHPRA, FDA, EMA, ICH guidelines, GCP, GMP
Responsibilities
Develop and implement global regulatory strategies for new drug applications (NDAs), Prepare and submit regulatory documents to health authorities, Liaise with regulatory agencies to address queries, Maintain up-to-date knowledge of evolving regulatory requirements, Oversee post-market regulatory activities, Mentor junior regulatory affairs personnel
Seniority
Senior, hands-on IC
