• Sun Pharma Job Opening in Drug Regulatory Affairs – US Group
• Job Overview
• Key Responsibilities
• Qualifications and Experience
• How to Apply

Sun Pharma, one of the world’s largest and most respected pharmaceutical companies, is dedicated to providing high-quality medicines for a healthier world. With a strong global presence, Sun Pharma has been making a significant impact on healthcare through its innovative pharmaceutical solutions.

Company Vacancies List

• Position Title: Drug Regulatory Affairs Executive / Sr Executive
• Company Name: Sun Pharma
• Job Location: Baroda, India
• Qualification: M.Pharm

Job Description

Sun Pharma Job Opening in Drug Regulatory Affairs – US Group

Company: Sun Pharma
Job Location: Baroda, India
Grade: Executive / Sr Executive
Qualification: M.Pharm

Job Overview

Are you a passionate pharmaceutical professional with a keen interest in regulatory affairs? Sun Pharma’s US Group has an exciting job opening for a Drug Regulatory Affairs Executive/Sr Executive. If you are an M.Pharm with a drive to contribute to the healthcare industry, this opportunity is for you. Join Sun Pharma and be part of a dynamic team that is dedicated to ensuring the highest quality medicines for patients.

Key Responsibilities

As a Drug Regulatory Affairs Executive/Sr Executive at Sun Pharma, your responsibilities will include:

1. Reviewing all data and documents related to product registrations for various health authorities.
2. Compiling registration dossiers for submission to various health authorities, including US-FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.
3. Preparing responses to deficiency letters received from various agencies.
4. Managing the life-cycle and post-approval changes for drug product registration dossiers.
5. Providing regulatory support to cross-functional departments.
6. Preparing and submitting scientific advice to various health authorities.
7. Handling eCTD compilation, verification, and submission through electronic gateways.

Qualifications and Experience

Position Title: Drug Regulatory Affairs Executive / Sr Executive
Qualification: M.Pharm
Experience: Freshers need not apply

How to Apply

If you are an M.Pharm professional looking to make a difference in the pharmaceutical industry and have the qualifications and experience required for this role, please send your resume to [email protected]. Freshers are kindly requested not to apply for this position.

_______________Below post expired don’t Apply________________________________________

job posted date; march 17, 2023 (Expired)

Sun Pharmaceutical Industries Limited – Baroda invites applications for openings in Drug Regulatory Affairs – (Market: Asia, Brazil, and LATAM)

Sun Pharmaceutical Industries Ltd. is an Indian multinational pharmaceutical company headquartered in Mumbai, India. The company specializes in developing and manufacturing generic and branded pharmaceuticals, as well as active pharmaceutical ingredients (APIs) and formulations.

Grade: Sr Executive / Manager
Qualification: M Pharmacy
Location: Baroda
Brief Job Description :
Regulatory submission of new products, variations, response to queries, Life cycle management for Asea, Brazil including other LATAM countries through the preparation of quality dossiers enabling timely approvals.

Area Of Responsibility:
1. New submissions:
a. Review & prepare CMC (Chemistry, Manufacturing, and Controls) dossiers for new submissions.
b. Review documents (Development report, scale-up report, specification, stability protocol), artworks, etc.
before initiation of Exhibit batches for adequacy.
2. Approval :
Review & prepare responses to deficiencies enabling approval of products filed to the regulatory agencies.
3. Lifecycle management for drug formulations:
a. Prepare and review variations as per the country requirements to support approval of changes such as API
vendor changes/changes in ROS/test parameters, DF site changes, harmonization of products etc.
b. Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies
4. Regulatory compliance:
a. Prepare, Review, and circulate the approval package to stakeholders upon receipt of approval and update the
same based on queries and variations.
b. Ensure reposition of comprehensive product information into a central repository
C. Review regulatory filing impact of variations, change controls, etc.

APPLICATION PROCESS; Send your resume to: [email protected]. Freshers need not apply