Dr. Reddy’s Regulatory Affairs Job in Hyderabad

Published on: September 24, 2026

Dr. Reddy’s Laboratories has listed an Associate Regulatory Affairs – External Manufacturing position in Hyderabad. The role is part of the North America business and involves regulatory submissions, post-approval activities, CMC documentation and coordination with external manufacturing partners.

This is an 8-month fixed-term position for maternity leave coverage.

1. Dr. Reddy’s Regulatory Affairs Job Details

2. What Is the Role About?

This role is focused on Regulatory Affairs work for products involving external manufacturing partners.

The position combines submission-related work with post-approval activities, CMC documentation, product lifecycle support and coordination with external partners.

The role is particularly connected with the US regulatory market, as it supports the North America business.

3. Main Responsibilities

4. What Does External Manufacturing Mean?

External manufacturing means that certain manufacturing activities are handled by an outside partner or Contract Manufacturing Organization (CMO).

For an RA professional, this can involve working with the CMO to obtain information needed for regulatory activities.

For example, the role may involve:

1. Requesting technical or regulatory documents
2. Reviewing information received from the manufacturing partner
3. Following up on pending documents
4. Supporting change-control activities
5. Coordinating information required for submissions

Candidates who have previously worked with manufacturing sites or external partners may find this part of the role familiar.

5. US Regulatory Knowledge

The vacancy refers to several areas of US Regulatory Affairs, including 21 CFR, ICH guidelines, CMC submissions, product filings, labelling and post-approval activities.

It also mentions:

• PAS – Prior Approval Supplement
• CBE-30 – Changes Being Effected in 30 Days
• CBE-0 – Changes Being Effected Immediately

For interview preparation, it is useful to understand when these submission routes are used and, more importantly, be able to discuss the regulatory work you have personally handled.

6. GDUFA Activities

The position also includes work related to GDUFA (Generic Drug User Fee Amendments).

The listed activities include:

• Establishment registration
• Self-identification
• Annual volume reporting

If you have handled these activities in a previous role, they are worth mentioning clearly on your resume.

7. What to Highlight on Your Resume

Rather than filling your resume with every possible RA keyword, focus on work that matches this vacancy.

Useful areas to highlight include:

• US regulatory submissions
• CMC documentation
• Post-approval changes
• Product filings
• Regulatory labelling
• CMO coordination
• Change controls
• Product launches
• Regulatory documentation
• GDUFA activities

Where possible, add a short description of what you actually did.

For example, instead of writing “CMC experience”, mention whether you prepared, reviewed or coordinated CMC documents for a particular type of submission.

For more opportunities in this field, see our Regulatory Affairs Jobs guide.

8. Interview Preparation

For an experienced RA role, practical examples from your previous work can be more useful than memorising definitions.

Prepare a few examples covering:

1. A regulatory submission you worked on
2. A post-approval change you supported
3. A situation where you coordinated documents with another team or manufacturing partner
4. A regulatory issue that required follow-up or problem-solving
5. Your involvement in a product launch or regulatory update

Be ready to explain your responsibility, the action you took and the outcome.

9. Who Is This Vacancy For?

The position is intended for professionals with relevant experience in generic pharmaceuticals and Regulatory Affairs.

The listed requirements include:

• Bachelor’s or Master’s degree in Life Sciences
• 4–6 years of generic pharmaceutical experience
• 3–6 years of Regulatory Affairs experience
• Knowledge of US regulatory requirements
• RAC certification as a desired qualification

This makes the opening more relevant to experienced RA professionals than fresh graduates.

10. Contract Details

The position is an 8-month fixed-term contract created for maternity leave coverage.

Candidates should consider the contract duration when evaluating the opportunity.

11. How to Apply

Interested candidates can apply through the official Dr. Reddy’s careers portal:

Apply for Associate Regulatory Affairs – External Manufacturing

You can also visit the Official Dr. Reddy’s Careers Page.

12. Frequently Asked Questions

What qualification is required?

The vacancy lists a Bachelor’s or Master’s degree in Life Sciences. RAC certification is highly desired.

Is this a fresher position?

No. The vacancy specifies prior experience in generic pharmaceuticals and Regulatory Affairs.

Does the role involve US Regulatory Affairs?

Yes. The position supports the North America business and includes US regulatory activities.

Does the role involve external manufacturing?

Yes. Coordination with Contract Manufacturing Organizations (CMOs) is part of the position.

What is GDUFA?

GDUFA stands for Generic Drug User Fee Amendments. The vacancy includes establishment registration, self-identification and annual volume reporting.

Is the position permanent?

No. It is an 8-month fixed-term position for maternity leave coverage.