Conducts biopharmaceutics studies to support drug product development. Designs and performs in-vitro dissolution method development and optimization. Establishes in-vitro in-vivo correlations (IVIVC) for oral drug products. Evaluates BCS classification of drug substances for regulatory strategies. Supports Biowaiver applications for solid oral dosage forms. Prepares biopharmaceutics sections for regulatory dossier submissions. Conducts food effect and DDI studies to support product labeling decisions. Collaborates with formulation and pharmacokinetics teams for product design. Reviews pharmacokinetic data and prepares population PK analysis reports. Designs in-vitro permeability and absorption studies using cell-based models. Supports bioequivalence study design and data interpretation activities. Evaluates dissolution specifications for product registration and lifecycle. Stays updated with FDA, EMA biopharmaceutics guidances and BCS classification.

Leads formulation development team for oral, topical, and parenteral products. Develops R&D strategy aligned with the company's new product pipeline. Reviews and approves formulation development reports and protocols. Manages project timelines, resources, and deliverables for R&D pipeline. Leads technology transfer activities from R&D to commercial manufacturing. Provides formulation expertise and guidance for ANDA and NDA dossier filings. Coordinates with regulatory affairs for technical sections of drug submissions. Manages CRO and CMO relationships for outsourced formulation development. Oversees pilot plant operations and scale-up activities. Establishes quality by design framework for new product development programs. Mentors junior scientists and builds technical capabilities in the R&D team. Manages R&D budget and ensures cost-effective product development. Stays current with novel drug delivery systems, CDMO partnerships, and regulatory trends.

Evaluates pharmacokinetics and pharmacodynamics of drugs in patients. Provides drug dosing recommendations for renal and hepatic impairment. Reviews polypharmacy cases and identifies critical drug interactions. Participates in hospital formulary decisions and evidence reviews. Conducts therapeutic drug monitoring for high-alert medications. Supports clinical trials from a pharmacology perspective. Provides expert opinions on medication-related adverse events. Collaborates with clinical pharmacists on complex medication queries. Contributes to rational drug use and antimicrobial stewardship programs. Develops clinical pharmacology educational programs for staff. Prepares pharmacological summaries for regulatory dossiers. Participates in pharmacovigilance and safety monitoring committees. Stays current with pharmacological research and clinical guidelines.

Position: Clinical Data Manager A dynamic organisation seeks an experienced Clinical Data Manager to take on a multifaceted and impactful role. This is an excellent opportunity for professionals who value structured career advancement and meaningful impact. Main Accountabilities: Provide clinical site training on data collection standards and regulatory requirements. Develop SOPs, work instructions, and training materials for clinical operations teams. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Review source data and ensure completeness, accuracy, and regulatory compliance. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Essential Skills and Experience: Collaborative, proactive, and able to operate effectively with minimal supervision. Superior writing and communication skills with experience preparing executive-level documents. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. 4+ years of experience with a demonstrated track record of growth and professional impact. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We look forward to welcoming a driven professional who shares our commitment to excellence and sustained impact.

Position: Clinical Data Manager A distinguished opportunity awaits a seasoned Clinical Data Manager within our progressive, innovation-led organisation. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Key Deliverables and Responsibilities: Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Provide clinical site training on data collection standards and regulatory requirements. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Professional Requirements: Demonstrated teamwork skills and the ability to build trust and rapport across functions. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. Hands-on experience with tools, software, and platforms standard to the profession. A structured, results-driven approach with the ability to meet defined milestones consistently. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Strong communication, presentation, and interpersonal skills across all organisational levels. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Applications are reviewed on a rolling basis; suitably qualified individuals are encouraged to apply promptly.