Senior Regulatory Associate
Core
Execute strategic regulatory activities to obtain and maintain Marketing Authorizations and support Clinical Trial Applications for human medicinal products across assigned markets.
Role type
Senior Regulatory Associate (Human Medicinal Products)
Builds
Regulatory submissions and strategies for new registrations, variations, and renewals
Domain
Life sciences / Human Medicinal Products / Regulatory Affairs
Required skills
Regulatory strategy, Marketing Authorization management, Clinical Trial Application support, NRA query management, Compliance management, Medical device regulation support, Good Regulatory Practice (GRP), Database management
Preferred skills
Master's degree or PhD, Professional Regulatory qualifications, Analytical thinking
Technologies
Regulatory databases
Responsibilities
Deliver regulatory strategy and advise cross-functional teams, manage new registration and variation applications, support strategic clinical development activities, obtain approvals for unlicensed medicines supply, safeguard compliance in packaging and prescribing information updates, support MA divestments and product discontinuations, contribute to Good Regulatory Practice (GRP), lead personal development
Seniority
Senior, hands-on IC