Regulatory Affairs Manager

2 weeks ago

bangalore, India Biocon Biologics Full time

Key Responsibilities: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.5. 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. 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.• 12-15 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.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 environment

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