MakroCare Regulatory Affairs Specialist Jobs For BSc Life Sciences, Apply on Biotecnika
Job Title: Regulatory Affairs Specialist (Publishing)
Company Name: MakroCare
Experience: 2 – 3 years
CTC: Competitive; hike on current CTC or market-aligned package
Number of vacancies: 1
Rounds of interview: 2 rounds Virtual
Qualification: B.Pharm / M.Pharm / Pharm.D / MSc / BSc in Life Sciences
Location: Hyderabad (Madhapur)
Job Summary:
We are seeking a skilled and detail-oriented Regulatory Affairs Specialist (Publishing) to join our Regulatory Affairs team in Hyderabad. The ideal candidate will be responsible for preparing, reviewing, and managing global regulatory submissions with a strong focus on CTD/eCTD dossier publishing. This role requires close collaboration with cross-functional teams to ensure regulatory compliance, timely submissions, and adherence to international guidelines.
Key Responsibilities:
• Lead preparation, compilation, and publishing of CTD/eCTD dossiers for global regulatory submissions.
• Manage the complete submission lifecycle – planning, formatting, publishing, and final submission.
• Ensure submissions meet technical and regulatory requirements as per global health authority standards (FDA, EMA, MHRA, CDSCO, etc.).
• Perform gap analysis of regulatory and manufacturing documents (MFC, BMR, Stability, Validation).
• Review documentation to identify missing data, inconsistencies, or compliance issues and recommend corrective actions.
• Collaborate with cross-functional teams (Manufacturing, QA
• Ensure timely and compliant responses to regulatory authority queries.
• Stay updated with global regulatory publishing standards and guidelines.
• Support process improvements and adoption of best practices in regulatory publishing.
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