Senior Regulatory Associate

Job description

JOB SUMMARY: Under the supervision of line management or guidance from an experienced Senior Regulatory Manager, conduct agreed strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs. JOB RESPONSIBILITIES: - Deliver Regulatory Strategy and Advise Cross-Functional Teams - Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests. - Manage New Registration/Marketing Authorization Applications - Manage Marketing Authorization (MA) Variation Applications - Manage MA Renewal Applications - Management of NRA queries - Develop knowledge of NRA’s expectations, ways of working etc. to inform assigned product regulatory strategies. Share updates and regulatory intelligence with colleagues. - Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network. - Respond to spontaneous requests from authorities promptly and accurately. - Support the strategic clinical development acti...