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Regulatory Affairs (RA) Specialist

Posted by Kavimani V

Job Overview

These professionals act as the link between the company and government agencies (like the FDA or EMA) to ensure products meet legal requirements for approval.

Responsibilities

Submissions: Prepare and submit dossiers for new drug applications, clinical trial authorizations, and marketing renewals. Strategy: Advise R&D teams on regulatory requirements to streamline the path to market. Labeling: Review product labeling, packaging, and marketing materials for legal compliance. Policy Tracking: Stay updated on changing global regulations and assess their impact on current projects.

Requirements

Degree in a scientific field (Biotech, Chemistry, or Pharmacology). High attention to detail and excellent technical writing skills.

Skills & Competencies

Mandatory Skills   

  • EMA
  • FDA
  • Labeling
  • Policy Tracking
  • Regulatory Affairs (RA)
  • Submissions

Job Benefits

Education

Job details

Job Status
Cancelled
Location
Bengaluru, Karnataka, India
Experience
2 - 6 years
Employment Type
Permanent
Salary
₹700,000 - ₹2,000,000 (Annual)
Mode of work
Any (Office / Hybrid / Remote)
No. of Positions
-
Work Type
-

Company Info

Company Full Name
Nicheton Consulting LLP
Company Short Name
Nicheton
Industry
Recruitment & Staffing
Company size
24
Founded on
06-Feb-2018
Location
Bengaluru, Karnataka
Presence in
1 Country

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