Unichem Laboratories is a leading Indian pharmaceutical company engaged in the development, manufacturing, and marketing of high-quality generic and branded formulations across global markets. The company has strong expertise in regulated markets including US, EU, ANVISA, and ROW submissions.
đź’Ľ Job Overview
- Position: Research Associate – Clinical Research
- Department: Research & Development
- Industry: Pharmaceutical & Life Sciences
- Employment Type: Full Time, Permanent
- Location: Panaji / Panjim, Goa
- Experience Required: 2–4 Years
- Education: M.Pharm / M.Sc (Science)
Unichem Laboratories is hiring a Research Associate – Clinical Research with strong experience in bioequivalence (BE) studies, LCMS-MS bioanalytical review, regulatory submissions, and GCP/GLP compliance.
This role is ideal for professionals looking to advance their career in clinical research, bioanalytical auditing, regulatory affairs, and BA/BE study design.
🔬 Key Responsibilities
The Research Associate – Clinical Research will be responsible for:
- Reviewing LCMS-MS bioanalytical method development and validation reports
- Evaluating ELISA and LCMS-MS bioanalysis of small & large molecules
- Reviewing BE study sample analysis reports
- Preparing and reviewing SOPs as per regulatory guidance
- Conducting onsite and retrospective audits for bio studies
- Ensuring compliance with GCP, GLP, SOPs, and study protocols
- Handling BE bioanalytical regulatory queries and deficiencies
- Performing root cause analysis for deviations
- Reviewing clinical & bioanalytical reports for ANDA / EU / ANVISA / ROW submissions
- Preparing BTIF (Bioequivalence Trial Information Form)
- Evaluating PK data from pilot & pivotal BA/BE studies
- Managing toxicity studies, PDE calculations & impurity assessments
- Understanding DCGI requirements for BE NOC & import licenses
🎯 Desired Skills & Competencies
Candidates should have:
- Strong knowledge of ICH GCP guidelines
- Experience in bioequivalence study design
- Expertise in BE protocol preparation
- Hands-on experience in CRO auditing & monitoring
- Experience handling eCTD regulatory submissions
- Understanding of ANDA submission process
- Knowledge of GLP compliance in preclinical studies
- Ability to manage regulatory deficiencies and health authority queries
🎓 Qualifications
- M.Pharm (Any Specialization)
- M.Sc (Life Sciences / Pharmaceutical Sciences / Related Field)
- 2–4 years of relevant experience in clinical research & BA/BE studies
đź’° Salary & Benefits (Estimated)
- Estimated Salary Range: ₹6,00,000 – ₹9,00,000 per annum
- Exposure to global regulatory markets
- Opportunity to work on regulated submissions (USFDA, EU, ANVISA)
- Career growth in clinical research & regulatory affairs
- Professional development in BA/BE compliance & auditing
đź“Ť Job Location
Panaji / Panjim, Goa – A growing pharmaceutical and clinical research hub with strong industrial presence and quality of life.
đź“© How to Apply
