Regulatory Affairs Manager

13 hours ago

Bengaluru, Karnataka, India Biocon Biologics Limited Full time ₹ 12,00,000 - ₹ 24,00,000 per year

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.

  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. 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.

  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:


• Bachelors or Masters degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus.


• 10-15 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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