Job Opportunity: Regulatory Affairs Specialist at Biocon Biologics

Job Summary

Biocon Biologics is seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our dynamic team in Bengaluru. This role is ideal for professionals with a strong background in biosimilars and international regulatory submissions, particularly within the MENA and CIS regions. As part of a globally recognized leader in biotechnology, you will play a pivotal role in ensuring our life-saving therapies reach patients by managing complex regulatory strategies, dossier preparations, and agency collaborations.

About Biocon Biologics

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a global leader in the development and manufacturing of affordable biosimilar therapies. Our portfolio spans critical therapeutic areas, including oncology, immunology, and diabetes. With a robust global presence, we are committed to transforming healthcare access and improving patient outcomes through innovation and excellence in science.

Responsibilities

As a Regulatory Affairs Specialist, your primary responsibilities will include:

Regulatory Strategy & Planning

• Develop and execute comprehensive regional regulatory strategies for the registration of biosimilar products.
• Ensure all strategies align with global regulatory goals and overarching business priorities.
• Perform thorough risk assessments and proactively implement mitigation strategies.

Dossier Preparation & Submission

• Prepare, review, and submit high-quality CTD/eCTD dossiers for new approvals, renewals, and product variations.
• Coordinate effectively with cross-functional teams to gather necessary technical documentation.
• Manage timelines to ensure all regulatory submissions are completed punctually.

Agency Engagement & Lifecycle Management

• Serve as the primary point of contact for health authorities, leading discussions to facilitate smooth approval processes.
• Collaborate with regional partners to gather market insights and streamline submissions.
• Oversee post-approval changes, annual renewals, and labeling updates while maintaining accurate internal regulatory databases.

Compliance & Cross-Functional Collaboration

• Monitor evolving regional regulatory guidelines to ensure full organizational compliance.
• Provide expert support during internal audits and external health authority inspections.
• Partner with Quality Assurance (QA), Quality Control (QC), Clinical, and Business Development teams to support product lifecycle management and partnership evaluations.

Requirements

To be successful in this role, you should possess:

• Education: A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
• Experience: Proven experience in pharmaceutical or biotech regulatory affairs.
• Specialized Knowledge: Mandatory experience managing regulatory submissions specifically for MENA and CIS regions.
• Technical Skills: Strong understanding of biosimilar regulatory pathways, ICH guidelines, and familiarity with SFDA and EMA reliance procedures.
• Professional Competencies: Excellent project management, organizational, and documentation skills. A strategic mindset with a high attention to detail is essential.

Benefits

We offer a competitive compensation and benefits package designed to support the well-being and professional growth of our employees:

• Salary: Estimated annual compensation between ₹6,00,000 and ₹12,00,000.
• Comprehensive Benefits: Includes health insurance and various employee wellness programs.
• Professional Development: Opportunities for continuous learning, training, and career progression within a global organization.
• Global Exposure: The chance to gain deep experience across diverse international regulatory markets.

How to Apply

If you are a motivated professional looking to make a global impact in the biosimilars space, we invite you to apply. Please visit the official Biocon Biologics careers portal or our LinkedIn job page.

Application Instructions: Please ensure your resume is updated and clearly highlights your specific experience with biosimilar products and your history of managing regulatory submissions for the MENA and CIS regions. We look forward to reviewing your application.