MSc Bioinformatics Job Vacancies Latest at Dr Reddy’s
Dr. Reddy’s Laboratories Ltd., a global leader in pharmaceuticals, is hiring a Regulatory Affairs Specialist in the Biologics division. This role involves managing dossier finalization, regulatory applications, compliance processes, and coordination with Quality Assurance teams. If you have expertise in life sciences and a passion for regulatory excellence, join our mission of accelerating access to affordable and innovative medicines—because Good Health Can’t Wait.
Job Summary
We are seeking a Regulatory Affairs Specialist to manage core regulatory activities, including dossier finalization, filing of regulatory applications, compliance, internal liaison for information compilation, and coordination with Quality Assurance teams during audits.
Roles & Responsibilities
- Finalize and manage dossiers: drafting, compilation, archival, and adherence to SOPs.
- File study applications for toxicity, clinical, and marketing authorization studies.
- Manage regulatory administrative requirements, including import/export licenses and permits.
- Act as internal liaison with CMC, non-clinical, and clinical SMEs for data compilation.
- Support Quality Assurance during audits, providing regulatory information for inspections.
- Execute IBSC activities, report compliance, and draft SOPs for regulatory processes.
- Draft and compile regulatory correspondences for CMC (APQRs, PACs) and clinical (Phase 4, PSURs, PILs, IBs).
- Design, customize, and maintain regulatory systems including eCTD, SharePoint, and DMS.
Qualifications
- Master’s degree in Life Sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, Regulatory Affairs, Pharmacy).
- Bachelor’s degree considered with sufficient regulatory experience.
- Minimum 2 years’ experience in regulatory affairs; biologics/biosimilar R&D experience preferred.
- Strong knowledge of IT platforms for regulatory systems (eCTD, DMS, RIMS).
Skills & Attributes
Technical Skills
- Ability to align strategies with evolving industry dynamics.
- Proficiency in regulatory information management systems.
- Strong analytical skills to assess regulatory risks and data.
Behavioral Skills
- Strong negotiation, interpersonal, and cultural sensitivity.
- High attention to detail with the ability to manage ad hoc priorities.
- Commitment to continuous learning and staying updated with regulations.
About the Department – Biologics
Dr. Reddy’s Biologics division leads the Global Biosimilars business, with a robust portfolio across key therapeutic areas. With decades of experience in clone development, bioanalytical processes, clinical trial execution, and commercial manufacturing, we are dedicated to delivering high-quality, affordable biosimilars globally. Over 900,000 patients have already benefited from our biosimilar products.
Benefits Offered
- Competitive industry-standard compensation and benefits.
- Relocation and joining support.
- Maternity & paternity benefits.
- Medical and life coverage for self and family.
- Personalized learning programs and professional development opportunities.
Learn more: Dr. Reddy’s Careers
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