"Makrocare Hiring in Hyderabad 2025 | Regulatory Affairs, CQA, Research, and Proposal Analyst Jobs"
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| (Makrocare Careers 2025) |
Makrocare, a leading global Clinical Research Organization (CRO) and regulatory solutions provider, is expanding its workforce in Hyderabad, India. The company is inviting applications from talented professionals in Regulatory Affairs, Clinical Quality Assurance (CQA), Research Analysis, and Proposal Management.
If you are a Life Sciences, Pharmacy, or Biotechnology graduate looking for growth in regulatory publishing, submissions, compliance, or clinical research, this is an excellent career opportunity.
Available Positions at Makrocare:-
1. Associate – Regulatory Affairs (Publishing):
- Experience: 1–3 years
- Location: Hyderabad
- Responsibilities:
- Prepare and compile eCTD/aCTD submissions for US/UK/EU/ROW.
- Conduct quality checks and ensure compliance with global regulatory standards.
- Collaborate with internal teams and respond to queries from regulatory authorities.
👉 Apply Here
2. Regulatory Affairs Specialist (Publishing):
- Experience: 2–4 years
- Location: Hyderabad (Madhapur)
- Responsibilities:
- Lead CTD/ACTD dossier preparation and submissions.
- Manage the complete submission lifecycle, publishing, and gap analysis.
- Review essential manufacturing documents (MFC, BMR, Stability, Validation).
👉 Apply Here
3. Research Analyst – I (Regulatory Bodies, Secondary Research):
- Experience: 1–3 years
- Location: Hyderabad
- Responsibilities:
- Conduct secondary research on regulatory bodies and clinical data.
- Compile drug/device profiles and regulatory intelligence reports.
- Track global regulatory changes and updates.
👉 Apply Here
4. Clinical Quality Assurance (CQA) – Associate:
- Experience: 2–3 years
- Location: Hyderabad (Madhapur)
- Responsibilities:
- Maintain SOPs, QMS, CAPAs, deviations, and audits.
- Conduct internal audits as per ISO and ICH-GCP guidelines.
- Provide training to staff on quality and regulatory standards.
👉 Apply Here
5. Proposal Analyst (Clinical CRO/Pharma):
- Experience: 2–6 years
- Location: Hyderabad
- Responsibilities:
- Develop clinical research proposals and analyze RFPs.
- Work closely with cross-functional teams to ensure accuracy in proposals.
- Ensure regulatory and funding compliance in all submissions.
👉 Apply Here
Qualifications & Skills Required:-
- Bachelor’s/Master’s in Life Sciences, Pharmacy, Biotechnology, or related fields.
- Experience in regulatory publishing, submissions, clinical QA, or proposal writing.
- Knowledge of ICH-GCP, ISO, CTD/eCTD standards, and regulatory guidelines.
- Strong documentation, analytical, and communication skills.
Why Join Makrocare?
- Work on global regulatory submissions.
- Exposure to diverse CRO and pharma projects.
- Career growth with cross-functional learning opportunities.
- Competitive salary and professional development.
How to Apply for Makrocare Careers:-
Interested candidates can apply directly via the official Naukri job links provided under each role. Make sure to submit an updated resume and relevant details.
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