Senior Regulatory Affairs Specialist

Biocon Biologics; Bengaluru; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading biotech firm in India is seeking a regulatory affairs specialist to develop regional regulatory strategies for biosimilar product registrations. Responsibilities include overseeing dossier submissions, engaging with health authorities, and managing post-approval changes. Ideal candidates should have a Bachelor’s or Master’s in a relevant field, experience in regulatory affairs especially for biosimilars, and strong project management skills. This role requires excellent communication and strategic thinking abilities.

Qualifications

• Experience in regulatory affairs in the pharmaceutical/biotech industry.
• Experience with regulatory submissions in MENA and CIS countries.
• Strong understanding of regulatory pathways for biosimilars.

Responsibilities

• Develop and implement regional regulatory strategies for biosimilar product registrations.
• Oversee the preparation, review, and submission of high-quality dossiers.
• Act as the primary point of contact for Health Authorities.

Skills

Regulatory affairs expertise

Project management

Strong communication skills

Strategic thinking

Cultural awareness

Education

Bachelor's or Master's degree in Pharmacy, Life Sciences or related field

Regulatory certification

Job description

Responsibilities

• 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.

Dossier Preparation & Submission

• 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, labeling 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 updates 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.