Associate Director Regulatory Affairs

4 weeks ago

Bengaluru, Karnataka, India Biocon Biologics Full time

Job Title

Associate Director / Sr. Manager - Global Regulatory Affairs

Department:

Regulatory Affairs

Responsibility:

Africa, Middle East, CIS & Non-EEA

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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