1. Regulatory Strategy & Planning

• 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.

1. 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.

1. 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.

1. 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.

1. Compliance & Intelligence





• 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.

1. 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.

Required 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 workplace.

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru