Regulatory Affairs Specialist

Biocon Biologics Limited; Bengaluru; Sur place; INR 1 800 000 - 2 700 000; Plein temps

Résumé du poste

Biocon Biologics Limited is seeking an experienced Regulatory Affairs professional to lead regional strategies for biosimilar registrations across MENA, CIS and neighboring markets.

Your role will ensure alignment with global regulatory strategy, manage dossier submissions, and engage Health Authorities to facilitate timely approvals while coordinating with cross-functional teams.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field; regulatory certification is a plus.
• 5–7 years in regulatory affairs in pharma/biotech, with ≥5 years in biosimilars preferred.
• Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity) 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; strategic thinking; proactive and collaborative.

Responsabilités

• Develop and implement regional regulatory strategies for biosimilars in MENA, CIS and neighboring regions.
• Oversee preparation, review, and submission of CTD/eCTD dossiers for new filings and renewals.
• Coordinate with CMC, non-clinical, clinical, and labeling teams to gather documentation.
• Engage Health Authorities as primary contact; lead discussions to facilitate approvals.
• Manage post-approval changes, renewals, labeling updates, and compliance reporting.
• Ensure timely updates of regulatory docs and databases across regions.
• Collaborate with QA, QC, SCM, PM, Clinical, Commercial, and BD to align priorities.

Connaissances

Regulatory affairs

Biosimilars

ICH guidelines

Regulatory submissions

Cross-functional collaboration

Formation

Bachelor's or Master's degree in Pharmacy or Life Sciences

Description du poste

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.

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.

6. 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.

5-7 years of experience in regulatory affairs in the pharmaceutical/biotech industry, at least 5 years' 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.