Regulatory Affairs – Biologics

Dr. Reddy’s Laboratories Ltd. is hiring a Regulatory Affairs Associate – Biologics for its Regulatory Affairs General function in Hyderabad, Telangana. The position is suitable for candidates with 3–5 years of experience in Biologics Regulatory Affairs and a Master’s degree in Life Sciences, Pharmacy or a related discipline.

Job Details

Company: Dr. Reddy’s Laboratories Ltd.
Position: Regulatory Affairs Associate
Department: Regulatory Affairs – Biologics
Job Function: Regulatory Affairs General
Location: Hyderabad, Telangana
Experience: 3–5 Years
Employment: Full-time

About the Role

The selected candidate will support regulatory activities related to biologics and biosimilar products, including preparation and compilation of regulatory dossiers, regulatory submissions, lifecycle management and compliance activities.

Key Responsibilities

• Prepare and compile regulatory documentation, dossiers and submission packages.

• Analyze regulatory guidelines, requirements and industry standards.

• Support preparation and submission of regulatory applications to relevant authorities.

• Conduct regulatory research and gap analysis.

• Collaborate with Quality Assurance, Product Development and Operations teams.

• Monitor changes in regulatory requirements and communicate updates to stakeholders.

• Assist in authoring dossier sections, regulatory query responses and variation applications.

• Support regulatory compliance documentation, tracking and reporting.

• Contribute to Regulatory Life Cycle Management activities.

• Maintain knowledge of applicable Good Pharmaceutical Practices and regulatory requirements.

Educational Qualification

Candidates should have a Master’s degree in Life Sciences or a related field, including:

• M.Pharm / Pharmacy

• Microbiology

• Biochemistry

• Biotechnology

• Bioinformatics

• Immunology

• Regulatory Affairs

• Other relevant Life Science disciplines

Experience Required

• 3–5 years of experience in Biologics Regulatory Affairs

• Additional experience in biologics/biosimilar R&D, process development or analytical development will be an advantage. (careers.drreddys.com)

Skills Required

Candidates should have:

• Good understanding of CMC, Non-Clinical and Clinical aspects of regulatory dossiers.

• Knowledge of ICH and LATAM regulatory guidelines.

• Understanding of global Regulatory Affairs and submission requirements.

• Familiarity with eCTD publishing, DMS and RIMS.

• Strong regulatory research and analytical skills.

• Ability to identify regulatory risks and potential compliance challenges.

• Excellent written, verbal and interpersonal communication skills.

• Strong logical, analytical and problem-solving abilities.

• Ability to collaborate effectively with cross-functional teams.

About the Biologics Department

Dr. Reddy’s Biologics business operates in the Global Biosimilars segment and has more than two decades of experience in developing, manufacturing and commercializing biosimilar products.

The department has end-to-end capabilities covering clone development, upstream and downstream process development, bioanalytical development, formulation, clinical development, regulatory affairs and commercial-scale manufacturing.

Benefits

Dr. Reddy’s offers career-development and employee benefits that include:

• Learning and development opportunities

• Personalized career-development programs

• Joining and relocation support

• Medical coverage

• Life coverage

• Maternity and paternity benefits

• Family support initiatives