Regulatory Affairs Officer

20 hours ago

Andheri West Mumbai Maharashtra, India Oxford Laboratories Pvt Ltd Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year
  • Oxford currently Looking for – Regulatory Affairs Officer for Mumbai H.Q.

Roles and Responsibilities:

The Regulatory Affairs Officer will provide support to the Regulatory Affairs Manager and assist in -

  • Independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents, registration samples etc. for timely registration of the products.
  • Preparation of Certificate of Analysis (COA) and other technical documents for Export.
  • Any queries in this regard either from Authorities of these countries, directly or through country head, as well as from the manufacturers of such products should be coordinated by you.
  • Maintaining Records related to regulatory documents
  • Verifying dossier related documents received from plant, FnD or outside agencies
  • Searching and Gathering documents of Innovator product.
  • Should have knowledge for pharmacovigilance and will be coordinating with the pharmacovigilance service providers and maintaining the complete activities regarding pharmacovigilance.

Job Qualifications and Skill Sets:

  • A Pharma Graduate or Post Graduate with a minimum of 2-3 years of relevant experience in Pharma Industry
  • Excellent written and verbal communication skills.
  • Proficient in Microsoft Office (Word, Excel)

Website :

Job Type: Full-time

Benefits:

  • Flexible schedule
  • Health insurance
  • Leave encashment
  • Provident Fund

Application Question(s):

  • What is your Current Annual CTC ?
  • What are your expectations in terms of salary ?
  • What is your Notice Period?

Education:

  • Bachelor's (Required)

Experience:

  • Regulatory reporting: 1 year (Required)

Work Location: In person

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