Profile Summary Clinical Development & Bioequivalence

The candidate will be responsible for end-to-end coordination and scientific oversight of Bioavailability/Bioequivalence (BA/BE) studies, Phase IV and Post-Marketing Surveillance (PMS) studies for pharmaceutical products intended for domestic and regulated markets.

The candidate should have hands-on experience in planning, monitoring and reviewing BA/BE studies, including CRO audit, study protocol review, clinical phase monitoring, bioanalytical data review, pharmacokinetic/statistical assessment and final study report review.

The role will also be responsible for preparation, compilation and scientific review of clinical and non-clinical sections/modules of regulatory dossiers, in coordination with Regulatory Affairs, for submissions to authorities such as UK MHRA, EMA/EU, TGA, USFDA and CDSCO/DCGI, as applicable.

The candidate should be capable of independently managing CROs and coordinating with clinical sites, investigators, bioanalytical laboratories, Regulatory Affairs, R&D; and Quality Assurance. Role & responsibilities

Preferred candidate profile :-

Key Responsibilities

BA/BE Study Strategy and Monitoring

- Prepare and review BA/BE study approach and development strategy based on product characteristics and target regulatory requirements.
- Review BA/BE study protocols, informed consent documents, CRFs, study-specific instructions and related clinical documentation.
- Monitor BE studies at CRO/clinical sites, including critical activities such as subject admission, dosing, sample collection and study conduct, as applicable.
- Ensure compliance with approved protocol, GCP requirements and applicable regulatory guidelines during study execution.
- Review protocol deviations, clinical observations, adverse events and other study-related issues.
- Track study progress from regulatory/ethics approval through clinical phase, bioanalysis, pharmacokinetic/statistical evaluation and final report.

Ensure timely completion of BE study deliverables and coordinate resolution of study-related

- observations with CROs.

Bioanalytical and PK/Statistical Review

- Review development and validation of bioanalytical methods using LC-MS/MS, HPLC or other appropriate techniques.
- Review bioanalytical method validation protocols, reports, chromatograms, sample processing sheets and analytical SOPs.
- Review bioanalytical study reports for compliance with GLP and applicable regulatory requirements.
- Review pharmacokinetic and statistical outputs, including Cmax,



AUC, Tmax, 90% confidence intervals and other relevant parameters.
- Assess overall study outcome and suitability of BE data for regulatory submission.

Clinical and Non-Clinical Dossier Modules

- Prepare, compile and scientifically review clinical and non-clinical dossier sections/modules for regulatory submissions.
- Review clinical summaries, study synopses, BA/BE reports, pharmacokinetic summaries and supporting clinical documentation.
- Review non-clinical pharmacology, pharmacokinetic and toxicology information relevant to the product and proposed regulatory pathway.
- Ensure consistency between clinical/non-clinical modules, study reports, product development information and regulatory strategy.
- Support preparation and review of relevant CTD/eCTD Module 2, Module 4 and Module 5 documentation, as applicable.
- Coordinate with Regulatory Affairs for compilation and submission of clinical and non-clinical documentation.
- Prepare and review responses to regulatory queries/deficiencies related to BA/BE, clinical, non-clinical, pharmacokinetic and bioanalytical data.

Phase IV and PMS Studies

- Support planning, protocol review and execution of Phase IV clinical studies and PMS programs.
- Monitor study progress, recruitment, protocol compliance, data collection and completion of regulatory commitments.
- Review Phase IV/PMS study documentation, interim updates and final study reports.
- Coordinate with CROs, investigators, pharmacovigilance and Regulatory Affairs regarding study conduct and safety-related observations.

CRO Selection and Management

- Identify and technically evaluate CROs for clinical, bioanalytical, Phase IV and PMS studies.
- Participate in CRO qualification and audits along with Quality Assurance.
- Review CRO capability, regulatory inspection history, technical suitability, timelines and study proposals.
- Maintain regular communication with CROs and ensure adherence to agreed project timelines and quality expectations.

Regulatory and Operational Support

- Prepare/support documentation for BE NOC, Test Licence/T-Licence, import permissions,



courier declarations and investigational product shipment.
- Coordinate procurement of RLD/RMP/comparator products and working/reference standards.
- Coordinate shipment, storage, documentation and reconciliation of investigational/test products.
- Prepare SOPs, study trackers, technical reports, scientific summaries and management presentations.
- Maintain study documentation and support inspection/audit readiness.

Preferred Qualification and Experience

- M.Pharm in Pharmacology / M.Sc. in Pharmacology or equivalent postgraduate qualification in Pharmacology.
- Candidates with a robust academic and professional background in clinical pharmacology, pharmacokinetics and non-clinical pharmacology/toxicology will be preferred.
- Relevant experience in the pharmaceutical industry, CRO or clinical research environment, preferably involving generic product development and regulatory submissions.
- Hands-on experience in planning and monitoring BA/BE studies, including protocol review, clinical phase monitoring and final study report review.
- Experience in review of bioanalytical method validation and bioanalytical study reports, preferably involving LC-MS/MS-based methods.
- Good understanding of pharmacokinetic and statistical evaluation of BE studies, including Cmax, AUC, Tmax and 90% confidence intervals.
- Demonstrated experience in preparation and scientific review of clinical and non-clinical CTD/eCTD documentation, particularly relevant sections of Modules 2, 4 and 5.
- Experience in reviewing non-clinical pharmacology, pharmacokinetics and toxicology information and assessing its adequacy for regulatory submission.
- Experience in preparation/review of clinical summaries, clinical overviews, study synopses and supporting clinical documentation.
- Exposure to Phase IV clinical studies and Post-Marketing Surveillance (PMS) studies, including study monitoring and report review.
- Experience in handling CROs and supporting submissions to CDSCO/DCGI and regulated markets such as EU/EMA, MHRA, TGA and/or USFDA is desirable.
- Valuable knowledge of ICH-GCP, GLP, BA/BE guidelines and applicable clinical and non-clinical regulatory requirements.

Core Requirement

The candidate should be a hands-on clinical development professional capable of independently monitoring BA/BE studies and scientifically reviewing the complete clinical and non-clinical package required for regulatory dossier submission, rather than functioning only as a study coordinator.

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