Dr. Reddy’s Laboratories Ltd. has announced an opportunity for a Regulatory Affairs Associate – Biologics in Hyderabad. This position is suitable for experienced regulatory affairs professionals with expertise in biologics or biosimilars, regulatory submissions, dossier preparation, lifecycle management and global regulatory requirements.
The Dr Reddy’s Regulatory Affairs Associate job in Hyderabad involves supporting regulatory applications, authoring dossier sections, responding to regulatory queries and coordinating with quality, development and operational teams. Candidates with strong knowledge of CMC, eCTD, RIMS, ICH guidelines and biologics regulatory affairs can consider this opportunity.
Dr. Reddy’s is a global pharmaceutical organization with operations across multiple countries and a significant presence in biosimilars and biologics development.
Key Responsibilities
Selected candidates for the Regulatory Affairs Associate – Biologics position will be responsible for:
- Preparing and compiling regulatory dossiers, submissions and supporting documentation.
- Supporting regulatory applications and submissions to relevant health authorities.
- Reviewing and interpreting regulatory guidelines, requirements and industry standards.
- Conducting regulatory research and gap assessments.
- Authoring and reviewing regulatory dossier sections.
- Preparing responses to regulatory authority queries.
- Supporting variation applications and post-approval activities.
- Managing regulatory lifecycle activities for assigned products.
- Collaborating with Quality Assurance, Product Development, Operations and other cross-functional teams.
- Monitoring changes in regulatory requirements and communicating relevant updates.
- Maintaining regulatory documentation, trackers and compliance records.
- Supporting adherence to applicable Good Pharmaceutical Practices.
- Identifying potential regulatory risks through critical analysis of regulatory information.
Qualification & Experience
Educational Qualification:
Master’s degree in a relevant life science discipline such as:
M.Pharm, M.Sc Biotechnology, M.Sc Microbiology, M.Sc Biochemistry, M.Sc Bioinformatics, M.Sc Immunology, M.Sc Life Sciences, Master’s in Regulatory Affairs, or other relevant postgraduate life-science qualifications.
Experience Required:
Candidates should have 3–5 years of experience in Biologics Regulatory Affairs.
Additional experience in biologics/biosimilar R&D, process development or analytical development will be advantageous.
Skills Required
Candidates should preferably have:
- Knowledge of global regulatory affairs and submission requirements.
- Understanding of ICH and LATAM regulatory guidelines.
- Knowledge of CMC, non-clinical and clinical sections of regulatory dossiers.
- Experience or familiarity with eCTD publishing.
- Understanding of Document Management Systems (DMS).
- Familiarity with Regulatory Information Management Systems (RIMS).
- Regulatory dossier preparation and lifecycle management skills.
- Ability to analyze regulatory information and identify compliance risks.
- Strong analytical and logical reasoning skills.
- Excellent written and verbal communication skills.
- Ability to collaborate effectively with cross-functional stakeholders.
Why Consider This Opportunity?
The role provides exposure to Dr. Reddy’s global biologics and biosimilars business. Professionals can gain experience across regulatory submissions, global guidelines, dossier management, CMC documentation and regulatory lifecycle management for biologic products.
Dr. Reddy’s states that employees may receive benefits including:
- Learning and professional development opportunities
- Joining and relocation support
- Medical coverage for employees and their families
- Life coverage
- Maternity and paternity benefits
- Career development and personalized learning programs
How to Apply
