Dr Reddys hiring Regulatory Associate

Dr. Reddy’s Laboratories Limited; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Dr. Reddy’s Laboratories in Hyderabad, Telangana, invites an experienced Regulatory Associate to join its global regulatory affairs team. You will handle dossier preparation, submissions, variations, renewals, and compliance support across product lifecycles.

The role emphasizes QA, PV collaboration, and cross-functional coordination with manufacturing and QA teams to ensure timely approvals and market access for products in regulated markets.

Qualifications

• 4–8 years of experience in Regulatory Affairs.
• Qualified in M Pharm, MSc, Industrial Pharmacy, or registered pharmacist.
• Strong knowledge of FDA, EMA and EU guidelines.
• Excellent written and spoken English communication skills.
• Proficiency in MS Excel, Google applications, and standard documentation tools.
• High attention to detail with the ability to manage multiple regulatory activities.

Responsibilities

• Prepare, compile, and submit regulatory dossiers to health authorities in line with global requirements.
• Manage lifecycle activities including variations, renewals, and post-approval changes.
• Support QA and Pharmacovigilance activities within regulatory programs.
• Coordinate with internal stakeholders to address regulatory queries and deficiencies.
• Develop and implement regulatory SOPs, risk management plans, and training programs.
• Assist in regulatory audits and inspections and support CAPA measures.

Skills

FDA/EMA guidance

English communication

MS Excel

Google Applications

Documentation practices

Cross-functional collaboration

Education

M Pharm

MSc

Industrial Pharmacy

Registered Pharmacy Professional

Tools

Regulatory databases

Documentation tools

MS Excel

Google Apps

Job description

Dr. Reddy’s Laboratories hiring Regulatory Associate in Hyderabad

Dr. Reddy’s Laboratories Ltd. is hiring a Regulatory Associate for its regulatory affairs operations in Hyderabad, Telangana. This role is designed for experienced regulatory professionals who want to work in a global pharmaceutical organization with strong exposure to product lifecycle management, regulatory submissions, quality systems, and pharmacovigilance-linked activities. The position plays a critical role in ensuring timely approvals, regulatory compliance, and sustained market access for pharmaceutical products across regulated markets.

Company Overview

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with operations spanning research, development, manufacturing, and commercialization across 66 countries. Founded in 1984, the organization has grown into a globally respected pharma major driven by deep science, strong governance, and a purpose-led mission to accelerate access to affordable and innovative medicines.

With over 24,000 employees worldwide, Dr. Reddy’s is known for its robust regulatory frameworks, compliance-driven culture, and commitment to sustainability, ethics, and diversity. The company’s long-standing presence in regulated markets such as the US and Europe makes it a strong platform for regulatory professionals seeking long-term growth and global exposure.

Job Role & Responsibilities

As a Regulatory Associate, you will be responsible for managing regulatory affairs activities across the product lifecycle, including dossier preparation, submissions, variations, renewals, and compliance support. The role requires close collaboration with cross-functional teams including Quality Assurance, Pharmacovigilance, and Manufacturing.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers to health authorities in line with global regulatory requirements
• Manage lifecycle management activities including variations, renewals, and post-approval changes
• Support regulatory activities related to quality management systems and pharmacovigilance
• Coordinate with internal stakeholders to ensure timely responses to regulatory queries and deficiencies
• Develop, review, and implement regulatory SOPs, risk management plans, and training programs
• Support internal and external regulatory audits and inspections
• Assist in investigation of compliance issues and implementation of CAPA measures
• Ensure alignment with FDA, EMA, and other global regulatory guidelines

This role directly contributes to regulatory compliance, product continuity, and patient access to medicines.

Required Education

Candidates must possess one of the following qualifications:
M Pharm, MSc, Industrial Pharmacy, Registered Pharmacy Professional

Experience Requirement

• 4 to 8 years of experience in Regulatory Affairs
• Prior exposure to Quality Assurance (QA) and Pharmacovigilance (PV) activities is preferred

Required Skills & Attributes

• Strong knowledge of FDA, EMA, and EU regulatory guidelines
• Excellent written and spoken English communication skills
• Proficiency in MS Excel, Google Applications, and standard documentation tools
• High attention to detail with the ability to manage multiple regulatory activities simultaneously
• Strong interpersonal skills and ability to work across cross-functional teams

Location & Salary

• Job Location: Hyderabad, Telangana, India
• Work Model: On-site
• Employment Type: Full-time

Salary details are not disclosed and will be aligned with Dr. Reddy’s compensation framework based on experience and role scope.

Why Build Your Regulatory Career with Dr. Reddy’s Laboratories

Regulatory roles at Dr. Reddy’s offer hands-on exposure to complex global submissions, lifecycle management strategies, and interactions with regulated health authorities. The organization’s strong compliance culture and global footprint provide regulatory professionals with long-term career stability and advancement opportunities into senior regulatory and leadership roles.

Working at Dr. Reddy’s allows professionals to contribute directly to the availability of high-quality, affordable medicines for patients worldwide.

Frequently Asked Questions (FAQs)

Is this role suitable for freshers?

No. This role requires 4–8 years of regulatory affairs experience.

Does this role involve global regulatory exposure?

Yes. The role involves working with FDA, EMA, and other global regulatory frameworks.

Is QA or PV experience mandatory?

QA and PV exposure is preferred but not mandatory.

Is this an onsite role?

Yes. This is a full-time onsite position based in Hyderabad.

What is the career growth after this role?

Career progression includes Senior Regulatory Associate, Regulatory Manager, and global regulatory leadership roles.