💼 Career Opportunity at Dr Reddy’s Laboratories: Regulatory Affairs Specialist – Pydibimavaram, Andhra Pradesh

Are you an experienced professional in regulatory affairs seeking a dynamic role at a globally respected pharmaceutical company? Dr Reddy’s Laboratories is hiring for the position of Regulatory Affairs Specialist at its Pydibimavaram facility in Andhra Pradesh. This full-time, on-premise opportunity is ideal for individuals with 6 to 12 years of experience in regulatory functions, particularly in dossier management, compliance, and coordination with internal and external stakeholders.

🌐 About Dr Reddy’s Laboratories

Founded in 1984, Dr Reddy’s Laboratories has grown into a multinational pharmaceutical powerhouse with a presence in 66 countries and a workforce of over 24,000 employees. A singular purpose drives the company: accelerating access to affordable and innovative medicines. With a strong foundation in science, sustainability, and people-centric practices, Dr Reddy’s is committed to reaching 1.5 billion+ patients globally by 2030.

📍 Job Details

Job Title: Regulatory Affairs Specialist

Location: Pydibimavaram, Andhra Pradesh, India

Employment Type: Full-Time

Experience Required: 6–12 years

Business Unit: IPDO (Integrated Product Development Organisation)

Work Mode: On-Premise

🎯 Role Summary

The Regulatory Affairs Specialist will be responsible for managing core regulatory activities, including dossier finalisation, regulatory filings, audit coordination, and compliance reporting. This role involves close collaboration with internal teams such as Quality Assurance, CMC, Clinical, and Non-Clinical SMEs, as well as external regulatory bodies.

🔍 Key Responsibilities

Finalise and manage dossiers, ensuring alignment with SOPs and regulatory systems.

File applications for toxicity studies, clinical trials, and marketing authorisations.

Handle regulatory permissions and licenses from the Ministry of Health and the Ministry of Science and Technology.

Act as a liaison for compiling regulatory information and responding to queries.

Coordinate with QA teams during audits and inspections.

Execute Institutional Biosafety Committee (IBSC) activities and report compliance.

Draft and compile regulatory correspondence related to CMC and Clinical documentation.

Maintain and customise regulatory information systems such as eCTD, DMS, and SharePoint.

🧠 Qualifications & Skills

 Education:

Master’s degree in Life Sciences, Pharmacy, Biotechnology, Biochemistry, or related fields.

A bachelor’s degree may be considered with relevant experience.

 Experience:

Minimum 2 years in regulatory affairs; experience in biologics or biosimilars is a plus.

 Technical Skills:

Familiarity with eCTD, DMS, and Regulatory Information Management Systems (RIMS).

Ability to analyse regulatory data and identify risks.

Behavioural Attributes:

Strong interpersonal and negotiation skills.

Attention to detail and ability to manage ad hoc priorities.

Commitment to continuous learning and regulatory updates.

Application Link: https://jobs.smartrecruiters.com/ni/DrReddysLaboratoriesLimited/37be18c1-bb71-4e20-a579-5f19a7f9a9cd-regulatory-affairs-specialist

 🌍 About the Biologics Department

Dr Reddy’s Biologics division is a leader in the Global Biosimilars market, with a robust pipeline covering over US\$80 billion in innovator sales. The team has end-to-end capabilities in clone development, process optimisation, and global trial execution. Over 900,000 patients have benefited from its biosimilar products to date.

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🎁 Benefits & Growth

Dr Reddy’s offers industry-leading benefits, including:

Personalised learning and development programs

Medical and life insurance coverage

Maternity and paternity support

Relocation assistance

Career advancement opportunities

📢 Final Thoughts

This is a compelling opportunity for professionals looking to make a meaningful impact in the pharmaceutical industry. If you’re passionate about regulatory compliance, documentation, and working in a purpose-driven organization, the Regulatory Affairs Specialist role at Dr Reddy’s Laboratories could be your next big career move.