Makrocare, a global leader in clinical research and regulatory solutions, is expanding its team in Hyderabad. The company is hiring across Regulatory Affairs, Clinical Quality Assurance (CQA), Research Analysis, and Proposal Management. If you are a life sciences or pharmacy graduate looking to grow your career in regulatory submissions, publishing, compliance, or clinical research, this is your opportunity.
Available Positions
1. Associate – Regulatory Affairs (Publishing)
- Experience: 1–3 years
- Location: Hyderabad
- Key Responsibilities:
- Prepare and compile eCTD/aCTD submissions for US/UK/EU/ROW.
- Conduct quality checks and ensure compliance with global guidelines.
- Collaborate with cross-functional teams and respond to regulatory queries.
2. Regulatory Affairs Specialist (Publishing)
- Experience: 2–4 years
- Location: Hyderabad, Madhapur
- Key Responsibilities:
- Lead CTD/ACTD dossier preparation and submission.
- Manage submission lifecycle, handle publishing, and perform gap analysis.
- Review manufacturing docs (MFC, BMR, Stability, Validation).
3. Research Analyst – I (Regulatory Bodies, Secondary Research)
- Experience: 1–3 years
- Location: Hyderabad
- Key Responsibilities:
- Conduct secondary research on regulatory bodies and clinical data.
- Compile drug/device profiles and regulatory intelligence reports.
- Stay updated with global regulatory changes.
4. Clinical Quality Assurance (CQA) – Associate
- Experience: 2–3 years
- Location: Hyderabad, Madhapur
- Key Responsibilities:
- Maintain SOPs, QMS, CAPAs, deviations, and audits.
- Conduct internal audits ensuring compliance with ISO and ICH-GCP.
- Train staff on quality and regulatory standards.
5. Proposal Analyst (Clinical CRO/Pharma)
- Experience: 2–6 years
- Location: Hyderabad
- Key Responsibilities:
- Develop clinical research proposals and analyze RFPs.
- Collaborate with teams for accurate proposal development.
- Ensure compliance with regulatory and funding guidelines.
Qualifications & Skills
- Bachelor’s/Master’s in Life Sciences, Pharmacy, Biotechnology, or related fields.
- Hands-on experience in regulatory publishing, submissions, clinical QA, or proposal writing.
- Strong knowledge of ICH-GCP, ISO, CTD/eCTD standards, and regulatory guidelines.
- Excellent communication, analytical, and documentation skills.
Benefits of Working at Makrocare
- Opportunity to work on global regulatory submissions.
- Exposure to cutting-edge CRO and pharma projects.
- Professional growth with cross-functional learning.
- Competitive salary and career progression.
How to Apply
Application Link for Associate – Regulatory Affairs
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Application Link for Regulatory Affairs Specialist (Publishing)
Application Link for Research Analyst – I (Regulatory Bodies, Secondary Research)
Application Link for Clinical Quality Assurance (CQA) – Associate
