An internationally known pharmaceutical company has an opening for a job RA Manager at their office in Beijing. The company has a strong reputation and a growing portfolio of more than 7,500 marketed products that serve patients in more than 165 countries and territories.
- Importing new drugs (portfolio brand products and generics) registration, including registration dossiers preparation, submission and following-up in a timely manner
- Communicating with regional/global colleagues and efficient communication with CDE staff/reviewers, to ensure projects move forward smoothly.
- Maintaining currently marketed products, including submitting variations and license renew in time based on current regulation and practice, and closely follow up registration activities such as local testing and validation, response to deficiency letters etc.
- Establishing and maintaining direct contact with global/regional regulatory team for RA information sharing and provide timely local RA support to assure projects going on track and meet local requirements.
- Keeping line manager informed for the progress of assigned project, ability to identify and discuss critical issues/risks and provide feasible solutions before implementation.
- Assisting on new products portfolio evaluation.
- Providing RA professional support to cross-functional teams.
- Completing tasks assigned by line manager.
Skills and Requirements:
- Master-degree or above, MSc in Pharmacy preferred.
- 5 or more years of import product regulatory experiences in related category.
- Ability to independently and effectively complete the registration projects for company assigned products.
- Knowledge of import drug registration, and familiar with NMPA regulations, policy, health system, registration procedure, and requirements in testing, importation etc.
- Knowledge of medicinal products regulations, policy in EMA, FDA, etc.
- Results-oriented, excellent ability to analyse and solve different problems during the whole registration, and fast self-study ability.
- Good verbal and written report writing and also presentation skills.
- Fluent in English verbal and written emails, also ability to t/c with colleagues in English.
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A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.