RA Manager

RA Manager

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Job details


Beijing
2019-07-04 11:19
28606
R&D/Science
Pharmaceuticals

Job description


Our client is a global pharmaceutical company offering a growing portfolio of more than 7,500 products, including prescription generic, branded generic, brand-name and bio-similar drugs, as well as over-the-counter (OTC) remedies.

Responsibility:

  • Be responsible for company new import drugs (portfolio brand products and generics) registration, including registration dossiers preparation, submission and following-up in a timely manner, keep well communication with regional/global colleagues and efficient communication with CDE staff/reviewers, so that to move project smoothly;
  • Be responsible for 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.;
  • Establish and maintain 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;
  • Keep line manager informed for the progress of assigned project, ability to identify and discuss critical issues/risks and provide feasible solutions before implementation;
  • Assist on new products portfolio evaluation;
  • Provide RA professional support to cross-functional teams;
  • Complete tasks assigned by line manager;


Qualification

  • Master Degree or above, MSc. in Pharmacy preferred;
  • 5 or more years of import or local 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 analyze 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;

Qualified and interested Parties please apply with your CV and latest salary in Word format to sophie.fan@morganphilipscn.com


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