Executive - Regulatory & Business Continuity

4 weeks ago

Vadodara, India SUN PHARMA Full time

Job Title:

Senior Executive /Manager 2 – Regulatory Affairs

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G11A/G11B

Location :

Baroda

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Summary

Regulatory submission of new products, variations, response to queries, Life cycle management for ASEAN markets (mainly Thailand) through preparation of quality dossiers enabling timely approvals.

Area Of Responsibility

1. New submissions:

a. Should be well-versed with country-specific requirements

b. Active participation in Regulatory strategy for new filings and LCM

c. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.

d. Review documents (Development report, scale up report, specification, stability protocol), artworks etc.

before initiation of Exhibit batches for adequacy

2. Approval :

Review & prepare response to deficiency enabling approval of products filed to regulatory agency.

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 approval package to stake holders upon receipt of approval and update the

same based on queries and variations.

b. Ensure reposition of comprehensive product information into central repository

C. Review regulatory filing impact of variations, change controls, etc.

Travel Estimate

NA

Job Requirements

Educational Qualification

M.Sc /M.Pharm

Experience

Tenure: 2-8 years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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