I am actively recruiting for a Beijing based Associate Regulatory Affairs Manager (12 month contract) for a global CRO to assist with the regulatory maintenance of a portfolio of vaccine products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The Associate Registration Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Associate Registration Manager ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Client’s Standard Operating Procedures, and may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.
Collaborate and Communicate with China PBG president on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:
- Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.
- Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.
- Develop an overall perspective of registration projects.
- Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.
- Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.
- Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and Client SOPs
- Maintain an up to date knowledge of the relevant legislation in China.
- Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.
- Provide regulatory advice to company personnel as required.
- Partner with the global regulatory and clinical development team in China PBG BUs for new products development strategy and inline products strategy.
- Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.
- Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Client policies, procedures, and practices
Ensuring Regulatory Compliance
- Ensure timely communicate the requirement of CHP and other China regulations to PGS, QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites
- Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and specification/manufacture process change
Tertiary qualifications in pharmacy or a science degree with a pharmacology major.
At least 3 years experience in vaccine regulatory affairs working.
- Strong Customer focus sense
- Excellent communication & interpersonal skills
- Excellent Teamwork/collaboration
- Result orientated
- Quality orientation
- Excellent ability to research information
- Able to work under pressure in a busy environment
- Good working knowledge of international and local regulatory guidelines and codes
- Good working knowledge of Microsoft Word, PowerPoint and Excel
- Excellent English skill in speaking, reading and writing
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