Regulatory Affairs Manager

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/A In 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