Are you an experienced Regulatory Publishing Specialist looking for a new opportunity? MakroCare, a leading name in the biotech, biopharma, and CRO industry, is hiring a Senior Regulatory Publishing Specialist in Hyderabad. If you have 3-6 years of experience in regulatory submissions, eCTD publishing, and CTD/ACTD dossier preparation, this could be your next career move!
Job Description: Sr. Regulatory Publishing Specialist
Key Responsibilities:
✔ Technical Document Preparation: Lead the preparation, review, and submission of CTD/ACTD dossiers for regulatory and non-regulatory markets.
✔ eCTD Publishing: Handle electronic regulatory submissions (eCTD) with high accuracy and compliance.
✔ Submission Build Activities: Manage submission builds, including inter-document linking, quality checks, validation, and timely dispatch.
✔ Collaboration with RA-Ops Team: Work closely with the Regulatory Affairs Operations team for smooth submissions.
✔ Manufacturing Document Review: Review critical documents like MFC, BMR, process validation reports, stability protocols, and PDRs.
✔ Response to Agency Queries: Prepare and review responses to regulatory agencies within deadlines.
✔ Regulatory Submissions Development: Ensure timely and compliant submission builds for assigned projects.
Qualifications & Skills Required:
✅ Education: Bachelor’s/Master’s degree in Pharmacy (B.Pharm/M.Pharm) or Life Sciences.
✅ Experience: 3-6 years in CRO/Biotech/Biopharma with hands-on experience in regulatory publishing, CTD compilation, and gap analysis.
✅ Technical Skills: Expertise in eCTD publishing, regulatory submissions, and dossier preparation.
✅ Soft Skills: Excellent communication & interpersonal skills to interact with sponsors and stakeholders.
About MakroCare
MakroCare is a globally recognized Regulatory, Clinical, and Compliance partner for pharmaceutical, biotech, and medical device companies. With a strong presence in Hyderabad, MakroCare provides end-to-end regulatory solutions, ensuring compliance with global standards.
Why Join MakroCare?
🔹 Work with industry-leading experts in regulatory affairs.
🔹 On-site full-time role in Hyderabad.
🔹 Opportunity to handle global regulatory submissions.
🔹 Growth-oriented work culture with learning opportunities.
