01 Oct
|
Globela Pharma
|
Sachin
01 Oct
Globela Pharma
Sachin
Job Summary
We are looking for an experienced Regulatory Affairs skilled with 3–4 years of relevant experience to manage regulatory submissions, documentation, compliance activities, and coordination with regulatory authorities.
Key Responsibilities
Prepare, review, and maintain regulatory dossiers and submissions.
Coordinate regulatory submissions, approvals, renewals, and variations.
Ensure compliance with applicable regulatory requirements and guidelines.
Review technical and regulatory documents for accuracy and completeness.
Coordinate with internal departments such as R&D;, Quality, Manufacturing, and QA.
Track regulatory submissions, queries, commitments, and approvals.
Support responses to regulatory authority queries and deficiencies.
Maintain regulatory databases, records, and documentation.
Monitor changes in applicable regulations and communicate relevant updates to stakeholders.
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related field.
3–4 years of experience in Regulatory Affairs.
Positive knowledge of regulatory documentation and submission processes.
Strong written and verbal communication skills.
Good attention to detail and documentation skills.
Ability to coordinate with cross-functional teams and manage multiple regulatory activities.
What We Offer
Competitive salary based on experience and skills.
Opportunity to work on diverse regulatory projects.
Qualified growth and learning opportunities.
Collaborative work environment.
Pay: ₹25,000.00 - ₹30,000.00 per month
Work Location: In person
📌 Regulatory Affairs Executive Sachin
🏢 Globela Pharma
📍 Sachin