Regulatory Affairs Manager

Biocon Biologics Limited · Bengaluru

  • Experience8–13 yrs
  • SalaryNot disclosed
  • Work modeonsite
  • Levelexecutive
  • Posted15 Sept 2026
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About Biocon Biologics Limited

Biocon Biologics Limited is hiring in Bengaluru in pharma biotech. This role looks for around 8+ years of experience.

Skills

  • biosimilar regulatory strategies
  • CTD
  • eCTD
  • regulatory risk assessment
  • regulatory submissions
  • MENA regulatory submissions
  • CIS regulatory submissions
  • ICH guidelines
  • SFDA
  • EMA reliance procedures
  • dossier localization
  • regulatory pathways
  • regulatory intelligence
  • post-approval lifecycle management

The role

A regulatory affairs manager at a pharmaceutical biotechnology company develops biosimilar regulatory strategies and oversees CTD and eCTD submissions across international markets. The role manages ICH guidelines, regulatory pathways, agency engagement, and post-approval lifecycle compliance.

Full job description

Job Description

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:

• Bachelors 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:

• 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.