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

In specific locations, the pay range may vary from the range posted.

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