Regulatory Affairs Job at Biocon Biologics | B Pharm/ M Pharm Graduates eligible
Looking for a Regulatory Affairs Job with a leading biopharmaceutical company? Biocon Biologics Careers has opened an excellent opportunity for experienced professionals to join as a Regulatory Affairs Specialist. This role offers exposure to global biosimilar registrations, regulatory strategy, dossier submissions, and health authority interactions across MENA, CIS, and Non-EEA regions.
- Job Title: Regulatory Affairs Specialist
- Location: Bengaluru
About the Company
Biocon Biologics is a leading biosimilars company committed to improving healthcare access globally through innovative biologic medicines. The company focuses on developing and commercializing high-quality biosimilars for patients across multiple international markets.
Job Description
Biocon Biologics is hiring a Regulatory Affairs Specialist responsible for supporting biosimilar registrations across the Middle East, North Africa, CIS, and Non-EEA markets. The role involves regulatory strategy development, dossier preparation, agency interactions, lifecycle management, compliance monitoring, and cross-functional collaboration.
Key Responsibilities
- Develop regulatory strategies for biosimilar product registrations across MENA, CIS, and Non-EEA markets.
- Prepare, review, and submit regulatory dossiers (CTD/eCTD) for product approvals, renewals, and variations.
- Coordinate with cross-functional teams to collect and manage submission documents.
- Communicate with health authorities and support regulatory approval processes.
- Work with regional partners and distributors for local regulatory submissions.
- Manage post-approval activities, including variations, renewals, and labeling updates.
- Monitor regional regulatory requirements and ensure ongoing compliance.
- Support regulatory inspections and provide regulatory intelligence updates.
- Collaborate with QA, QC, Clinical, Commercial, SCM, PM, and BD teams on regulatory priorities.
- Assist in business development, due diligence, and partnership evaluation activities.
Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, or related field; Regulatory certification is a plus.
- Experience in regulatory affairs in the pharmaceutical/biotech industry, with experience in biosimilars, is preferred.
- Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines.
- Experience with regulatory submissions in MENA and CIS countries is mandatory.
- Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements.
Skills & Competencies
- Strong project management and organizational skills.
- Excellent written and verbal communication skills.
- Strategic thinking with attention to detail.
- Proactive, collaborative, and culturally aware.
- Ability to manage multiple priorities in a fast-paced environment.
