• Work closely with global and local colleagues to advise and agree on regulatory strategy, clinical development plans , marketing plan as well as data requirements
• Manage regulatory submissions process and their compliance with regulation, prepare high quality submission packages and responses for clinical trials, new product license applications and variations, annual updates within applicable timelines
• Monitor and influence assessment process to expedite and optimise the outcome of their submissions, to ensure submissions are made in accordance with accepted regulatory standards within appropriate timeframes.
• Lead, maintain and develop communication with Regulatory Authorities and Regulatory consultants, drive negotiations to ensure best possible product labelling and delivery of their commitments and deadlines
• Proactively build relationships externally and internally, work closely and swiftly with cross functional teams to address critical issues
• Communication of any regulatory changes to the business as necessary
• Creation, submission and maintenance of official local drug information, including Patient Information Leaflets, and packaging texts
• Ensure promotional activities are compliant to relevant legislation, implement and ensure systems are established and maintained for Regulatory Affairs Document Management
• Participate in safety reviews for implementing appropriate safety updates, lead audit activities for regulatory function as required
• Other job related tasks as assigned