Regulatory Affairs Manager

19 hours ago

Bengaluru Karnataka India, Karnataka 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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