Chemical Engineering Job at Biocon Biologics | Apply for Regulatory Affairs Manager
Looking for Biocon Jobs in the pharmaceutical and biotechnology sector? Biocon Biologics is hiring for Regulatory Affairs Manager roles in Bengaluru, Karnataka. This opportunity is ideal for candidates searching for Regulatory Affairs Jobs, Chemical Engineering Jobs, and biotechnology careers with global exposure. Candidates with experience in CMC regulatory submissions, biologics, biosimilars, and CTD documentation can build a strong professional future through this exciting career opportunity at Biocon Biologics.
About Biocon Biologics
Biocon Biologics is a globally recognized biopharmaceutical company focused on developing high-quality biologics and biosimilars for patients worldwide. As a leading name in biotechnology and pharmaceutical innovation, Biocon Biologics offers exceptional career opportunities in Regulatory Affairs Jobs, research, manufacturing, and Chemical Engineering Jobs. The company promotes innovation, scientific excellence, and global healthcare advancement through advanced biologics development and regulatory expertise.
Job Overview
Biocon Biologics is seeking a skilled Regulatory Affairs Manager to support development, registration, and lifecycle management activities related to CMC regulatory affairs for biologics and biosimilars. The selected candidate will work closely with senior regulatory professionals and cross-functional teams to prepare, review, compile, and maintain CTD Module 3 documentation for global regulatory submissions. This role
offers excellent exposure to Drug Substance manufacturing processes, regulatory compliance, process validation, and global health authority interactions, making it an ideal opportunity for candidates interested in Biocon Jobs, Regulatory Affairs Jobs, and Chemical Engineering Jobs. The role supports development, registration, and lifecycle management of CMC activities for biologics/biosimilars. The incumbent will work closely with senior regulatory colleagues and cross-functional teams to support preparation, review, and maintenance of CMC regulatory content, ensuring compliance with global regulatory expectations.- Job Post: Regulatory Affairs Manager
- Location: Bengaluru, Karnataka,
Key Responsibilities
- Support preparation and review of Drug Substance manufacturing process descriptions for global regulatory submissions (CTD Module 3.2.S).
- Assist in the preparation of variation/supplement documentation associated with DS tech transfer activities.
- Support preparation, review, compilation, and publishing of CMC sections for:
- INDs / IMPDs
- BLAs / MAAs
- Variations / Supplements
- Maintain regulatory trackers for DS-related submissions, commitments, and agency interactions.
- Ensure documents comply with CTD format, regulatory guidance, and internal quality standards.
- Assist in ensuring consistency of DS process descriptions across development stages and markets.
- Work closely with Process Development, MSAT, QA, Manufacturing, and Analytical teams to gather regulatory inputs.
- Help maintain consistency of regulatory positions across regions.
- Assist senior team members in assessing data adequacy for regulatory submissions and post-approval changes.
- Support responses to health authority queries related to DS manufacturing processes.
- Support regulatory review of:
- Process development summaries
- Scale-down model qualification data
- Process characterization studies
- Process validation
- Hold time studies
- Resin re-use and lifecycle studies
- Viral clearance studies
Requirements
Education: Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, or related discipline.
Knowledge & Skills
- Basic to working knowledge of:
- Drug Substance manufacturing processes
- Process development and characterization concepts
- PPQ and validation principles
- Viral clearance and viral safety requirements
- Familiarity with ICH guidelines (Q5E, Q7, Q8, Q9, Q10, Q11)
- Ability to interpret scientific data and translate it into regulatory documentation
- Strong written communication and document-management skills
- Good coordination and stakeholder-management abilities
Behavioral Competencies
- Strong attention to detail and compliance focus
- Willingness to learn and grow in CMC regulatory complexity
- Structured, organized, and accountable
- Comfortable working in cross-functional and matrix environments
Biocon Biologics offers one of the best Regulatory Affairs Jobs for candidates passionate about biologics, biosimilars, and pharmaceutical innovation. With opportunities to work on global regulatory submissions, advanced CMC documentation, and scientific collaborations, this role provides excellent professional growth in biotechnology and Chemical Engineering Jobs. Candidates seeking Biocon Jobs in Bengaluru with long-term career development and international regulatory exposure should not miss this opportunity.
