In compliance with submission plan for new products approval and maintain existing products including PMF & DMF submission & subsequence maintenance.
Provide supports and demonstrate leadership to DRA function including leading and guidance for junior DRA members or other business partners.
Support and collaborate with various departments for fulfilling company objectives.
Ensure regulatory and company compliance to Corporate Standards, local and international regulatory requirements.
Support and lead for new product submissions including biosimilars to TFDA
Make the best dossier submission for smooth approvals
Giving reliable estimation on MA dates, risk assessment
Negotiate with local HA about any disagreements on our applications
Escalate and actively participate for higher level discussions if local investments required
Perform post-marketing product maintenances jobs, including centralized databases on regulatory activities; perform regular follow ups on assigned products and tasks according to business priorities.
Ensure effective product maintenance and variations applications for existing products (DMFs, PMFs, license renewals, variations, others)
Keep abreast of the local and global regulatory / political environment and proactively lead for regulatory discussions and preparations.
Update the global / regional regulatory requirements as if applicable
Proactively discuss with regulatory personnel (including Novartis Pharma) for regulatory changes or requirements, ensure alignment within Sandoz DRA personnel
Assist in the development of regulatory strategy and update strategy based upon regulatory changes
Establish & maintain good relationship with local HA
Obtain regulatory news / competitive intelligence and escalate for discussions if applicable
Act as interim and represent Sandoz for lobbying on key regulatory issues
Assistant Department Head in regional and global DRA projects & initiatives
Assist Department Head to work with portfolio & Launch, sales / marketing and BD&L Managers to ensure alignment on portfolio strategy, disease area strategy, external licensing, others
Work with Marketing Head on lobbing strategy with respect to TFDA, BNHI, Ministry of Foreign Affairs, TIPO, and other key government stakeholders.
Support business partners including sales for commercial needs (e.g. listing requests)
Support new launches management including Supply Chain (SCM), Quality Assurance (QA) to ensure timely regulatory preparations, including artworks, PSAs, launch limiting variations to ensure on-time shipments to Taiwan
Ensure proper filing and records keepings for regulatory documents, including tracking and control systems.
Assist in departmental improvements and initiatives for corporate projects.
Supports ad-hoc tasks assigned by line manager or Country Head