Unichem Laboratories, a well-established pharmaceutical company known for its research-driven drug development and global regulatory presence, is hiring a Research Associate – Clinical Research in Panaji, Goa.
This opportunity is ideal for professionals with 2–4 years of experience in bioequivalence (BE) studies, bioanalytical method development, LC-MS/MS analysis, and regulatory submissions.
Candidates with experience in clinical research, pharmacokinetics (PK) data evaluation, GLP/GCP compliance, and CRO audit management will find this role particularly aligned with their career growth in pharmaceutical R&D and regulatory science.
Job Details
- Position: Research Associate – Clinical Research
- Company: Unichem Laboratories
- Location: Panaji / Panjim, Goa, India
- Experience: 2–4 Years
- Employment Type: Full Time
- Department: Research & Development
- Industry: Pharmaceutical & Life Sciences
Key Responsibilities
The selected candidate will support clinical research and bioequivalence study activities including regulatory compliance, bioanalytical data review, and CRO oversight.
Primary responsibilities include:
- Review LC-MS/MS bioanalytical method development and validation reports.
- Evaluate bioequivalence (BE) study sample analysis reports.
- Prepare and review Standard Operating Procedures (SOPs) aligned with regulatory guidance.
- Review ELISA and LC-MS/MS bioanalytical data for small and large molecules.
- Conduct onsite and retrospective audits of CROs for clinical and bioanalytical studies.
- Ensure compliance with GLP, GCP, and regulatory requirements.
- Identify root causes for deviations and non-compliance in study data.
- Provide regulatory guidance for resolving bioanalytical queries and deficiencies.
- Support preparation and review of bioanalytical reports for regulatory submissions.
Required Qualifications
Candidates applying for this Clinical Research Associate / Research Associate role should have the following qualifications:
- M.Pharm or M.Sc in Life Sciences / Pharmaceutical Sciences
- 2–4 years of experience in clinical research or bioequivalence studies
- Knowledge of ICH-GCP guidelines
- Understanding of bioanalytical techniques including LC-MS/MS and ELISA
- Experience in clinical trial documentation and regulatory compliance
Preferred Skills
Applicants with the following expertise will have a competitive advantage:
- Experience in bioequivalence (BE) study design and protocol preparation
- Ability to evaluate pharmacokinetic (PK) data from BA/BE studies
- Experience reviewing clinical research CRFs and bioanalytical reports
- Familiarity with eCTD submissions and regulatory query management
- Knowledge of DCGI regulatory requirements for BE NOC and import licenses
- Experience conducting CRO audits and monitoring bioanalytical studies
- Understanding of toxicity studies, impurity evaluation, and PDE calculations
Benefits of Working at Unichem Laboratories
Joining Unichem Laboratories provides professionals with opportunities to work in advanced pharmaceutical research and regulatory development environments.
Key benefits include:
- Exposure to global regulatory submissions (ANDA, EU, ANVISA, ROW markets)
- Opportunity to work on bioequivalence studies and pharmacokinetic data analysis
- Experience with clinical research audits and regulatory compliance frameworks
- Career growth in clinical research, regulatory affairs, and pharmaceutical R&D
How to Apply
