RA Manager

KEY ACCOUNTABILITIES:

• Develops and ensures implementation of regional RA strategy for Opella products.
• Serves as focal point between Affiliate RA and other RA functions.
• Responsibility of various registered products. Ensures the maintenance of renewals, variations, answers to the authorities, the coordination of the preparation of reports profit / risk.
• Extension of the recordings: evaluation of files, coordination of the update of the documentation, the definition of the strategies of recording.
• Proficient in drug license maintenance, including: license renewal, variations, new drug registration etc. for domestic and imported drugs, especially for OTC drugs
• In charge of prepare registration dossiers, follow up registration procedure, get final registration permits
• Follow up registration status, being the contact with province MPA, NMPA, CDE, ChP, inspection agencies and external pharmaceutical organizations.
• Contact GRA and provide guidance on NMPA requesting documentation and notarizations
• Represent regulatory affairs on cross-functional product/project teams and provides regulatory advice.

Education:

• Bachelor degree in pharmacy or nutrition field

Experience & knowledge:

• Minimum 10 years working experience in pharma/healthcare food. Industry
• Over 10-15 years experience in registration field especially for healthcare registration

Core competencies:

• Good computer skill in EXCEL, POWERPOINT and WORD;
• Good interpersonal communication skill;
• English skill both in spoken and written
• Team leader