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. 2.

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. 3.

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. 4.

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.




- 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.
- 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:

- Robust 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.

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 Biocon
📍 Bengaluru