Regulatory Affairs Manager

Job description

JOB DESCRIPTION: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 Education: • A 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 The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Regulatory Operations DIVISION:EPD Established Pharma LOCATION:China > Shanghai : 388 W. Nanjing Road, Ciros Plaza ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Not specified MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Not Applicable