Regulatory Affairs Specialist

Biocon Biologics; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Biocon Biologics in Bengaluru, India, is seeking a Regional Regulatory Affairs Lead to shape biosimilar submissions across the Middle East, North Africa, CIS, and other non-EEA markets. You will coordinate with QA, QC, and commercial teams to align regulatory plans with global strategy and manage life-cycle submissions.

The role requires strong communication, project management, and hands-on experience in MENA and CIS regulatory pathways, with a focus on timely approvals and inspections.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences or related field.
• Experience in regulatory affairs for pharma/biotech, biosimilars preferred.
• Knowledge of biosimilar regulatory pathways and ICH guidelines.
• Experience with regulatory submissions in MENA and CIS countries mandatory.
• Strong project management and organizational skills.

Responsibilities

• Develop regional regulatory strategies for biosimilar registrations.
• Prepare, review, and submit CTD/eCTD dossiers.
• Coordinate with CMC, non-clinical, clinical, and labeling teams.
• Engage with Health Authorities and regional partners.
• Monitor guidelines and provide regulatory updates to leadership.

Skills

Regulatory strategy

Dossier submission

Regulatory intelligence

Cross-functional collaboration

Project management

Written & verbal communication

Education

Bachelor’s or Master’s degree in Pharmacy/Life Sciences

Job description

• Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries.
• Ensure alignment with global regulatory strategy and business priorities.
• Conduct regulatory risk assessment and provide mitigation strategies during planning and execution.
• Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations.
• Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation.
• Ensure submission timelines are met as per business needs and agency expectations.

Agency Engagement & Partner Coordination

• Act as the primary point of contact for Health Authorities in these regions.
• Lead technical and administrative discussions with regulatory agencies to facilitate approvals.
• Collaborate with regional distributors/partners for local submissions and regulatory intelligence.

Lifecycle Management

• Manage post-approval changes (variations), renewals, labelling updates, and compliance reporting.
• Ensure timely implementation of changes across the region.
• Maintain up-to-date regulatory documentation and databases.
• Monitor and interpret regional regulatory guidelines, regulations, and policies relevant to biosimilars.
• Provide periodic update on impact and compliance to regulatory head.
• Support regulatory inspections as needed.

Cross-functional Collaboration

• Work with QA, QC, SCM, PM, Clinical, Commercial, and BD teams to align regulatory priorities.
• Support business development activities, due diligence, and partnership evaluations for the region.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus.
• Experience in regulatory affairs in the pharmaceutical/biotech industry, 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.
• 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.