Regulatory Affairs Manager

Primary Job Function 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 Minimum EducationA Bachelor’s degree or above in pharmacy, biology, chemistry, pharmacology or related life sciences is required Minimum Experience/Training Required Industry experiences : A minimum of 6 years experience required in Regulatory, R&D or related area Position experiences :Minimum of 4 years experience preferred in pharmaceutical regulatory affairs. Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies. Experience in Woman Health, CV, Vaccine, etc. is a plus Language Skills：Fluent English both oral and written Mobility : May need travel Other Special requirement :Experience working in a complex and matrixed environment is required Dependent on individual aptitude with experience of a broad range regulatory work in the ethical pharmaceutical industry Management experience - Up to date knowledge of legislation