Unichem Laboratories Hiring Research Associate Clinical Research in Goa. Apply BA BE regulatory jobs with global pharma exposure opportunities.
Company Overview
Unichem Laboratories is a well-established Indian pharmaceutical company with a strong presence in formulations, active pharmaceutical ingredients (APIs), and regulated global markets. With decades of expertise in drug development and regulatory submissions, the company serves major markets including the US, Europe, and emerging regions.
Known for its research-driven approach, Unichem focuses on bioequivalence (BE) studies, clinical research, and regulatory compliance across multiple therapeutic areas. The organization offers strong opportunities for professionals seeking careers in clinical research, bioanalytical sciences, and regulatory strategy. Unichem Laboratories Hiring Research Associate Clinical Research
Job Location & Employment Type
- Location: Panaji / Panjim, Goa
- Employment Type: Full-time, Permanent
- Department: Clinical Research / Regulatory Sciences
- Experience Required: 2–4 years
Open Position
Research Associate – Clinical Research
Function: Bioequivalence & Clinical Research Compliance
This role is ideal for professionals with experience in BA/BE studies, bioanalytical evaluations, and regulatory documentation. It involves cross-functional work across clinical research, bioanalytics, and regulatory compliance. Unichem Laboratories Hiring Research Associate Clinical Research
Key Roles & Responsibilities
The Research Associate will be responsible for reviewing bioanalytical data, supporting regulatory documentation, and ensuring compliance with global guidelines. Unichem Laboratories Hiring Research Associate Clinical Research
Bioanalytical Review & Evaluation
- Review LC-MS/MS bioanalytical method development and validation reports.
- Evaluate BE study sample analysis outputs for accuracy and compliance.
- Assess ELISA and LC-MS/MS data for small and large molecules.
- Ensure alignment with GLP standards and regulatory expectations.
Clinical Research Compliance
- Support preparation and review of SOPs aligned with regulatory guidance.
- Conduct audits of bioequivalence studies to ensure GCP/GLP compliance.
- Perform onsite and retrospective study audits.
- Identify deviations and recommend corrective actions.
Regulatory Documentation & Strategy
- Handle bioanalytical regulatory queries and deficiencies.
- Provide regulatory inputs for clinical and bioanalytical data reviews.
- Support submission documentation for regulated markets.
- Assist in preparing compliance documentation for global filings.
BA/BE Study Design Support
- Contribute to design and evaluation of bioequivalence studies.
- Review BE protocols across therapeutic categories.
- Assess pharmacokinetic (PK) data from pilot and pivotal studies.
- Ensure adherence to regulatory expectations for study design.
CRO Oversight & Auditing
- Participate in auditing and monitoring of CRO partners.
- Review clinical and bioanalytical reports from external vendors.
- Ensure compliance with study protocols and regulatory standards.
Additional Responsibilities
- Support preparation of regulatory submission documents.
- Handle regulatory queries related to BE studies and eCTD filings.
- Provide inputs on toxicity studies and impurity assessments.
- Maintain compliance with evolving regulatory frameworks.
Unichem Laboratories Hiring Research Associate Clinical Research
Eligibility Criteria
Education
Candidates must have:
- M.Pharm
OR - M.Sc / MS in Life Sciences or related disciplines
Candidates with specialization in pharmacokinetics, pharmaceutics, or regulatory sciences will have an advantage. Unichem Laboratories Hiring Research Associate Clinical Research
Experience
- 2–4 years of experience in:
- Clinical research
- Bioequivalence studies
- Bioanalytical or regulatory environments
Experience in regulated market submissions is preferred.
Skills Required
- Strong knowledge of BA/BE study requirements.
- Familiarity with ICH-GCP and GLP guidelines.
- Experience reviewing clinical and bioanalytical reports.
- Understanding of pharmacokinetics and PK data evaluation.
- Knowledge of regulatory submissions (ANDA, EU, ROW).
- Exposure to CRO audits and monitoring activities.
- Ability to handle regulatory queries and deficiencies.
- Familiarity with eCTD submission requirements.
- Understanding of DCGI requirements for BE approvals.
- Strong analytical and documentation skills.
Salary & Benefits
- Salary: Not disclosed (as per company norms)
Potential benefits may include: - Exposure to regulated global markets
- Strong learning in BA/BE regulatory science
- Career growth in clinical and regulatory domains
- Opportunity to work with experienced R&D teams
Compensation will depend on experience and internal company policies.
Selection Process
The hiring process typically includes:
- Resume screening
- HR interview
- Technical discussion (BA/BE and regulatory focus)
- Final selection round
The process may vary depending on candidate experience.
How to Apply
Candidates can apply through the official job portal where the listing is published.
Ensure your CV highlights:
- BA/BE study experience
- Bioanalytical evaluation expertise
- Regulatory submission exposure
- CRO audit experience
Early applications are recommended due to limited openings. Unichem Laboratories Hiring Research Associate Clinical Research
Important Dates
- Application Deadline: Not specified
Candidates are encouraged to apply at the earliest.
Why Apply for This Pharma Job?
This Unichem Laboratories opportunity is ideal for professionals aiming to specialize in bioequivalence and regulatory clinical research. Key benefits include:
- Strong exposure to BA/BE regulatory science
- Experience with global submission standards
- Opportunity to work in regulated markets
- Hands-on involvement in audits and compliance
- Career growth in clinical and regulatory R&D
If you want to build expertise in BE studies and regulatory submissions, this role offers a strong career pathway. Unichem Laboratories Hiring Research Associate Clinical Research
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform sharing verified pharmaceutical and clinical research job opportunities. We are not affiliated with Unichem Laboratories or any hiring organization. Applicants should verify job details independently and apply through official platforms only. Unichem Laboratories Hiring Research Associate Clinical Research
Final Call-to-Action
If you have experience in bioequivalence studies and want to grow in regulatory clinical research, this Unichem Research Associate role is a strong opportunity. Apply now and advance your career in BA/BE and regulatory science. Unichem Laboratories Hiring Research Associate Clinical Research
