Performs method development and method validation using HPLC and UPLC systems. Conducts routine HPLC analysis for raw material, in-process, and finished products. Operates and maintains HPLC instruments, manages column library and qualification. Performs forced degradation and stability-indicating method development studies. Investigates chromatographic failures and OOS results systematically. Prepares analytical protocols and validation reports per ICH Q2R1 guidelines. Reviews analytical data and approves laboratory notebooks and test reports. Transfers analytical methods between laboratories and manages qualification. Supports regulatory submissions with analytical data and validation packages. Trains junior analysts on HPLC techniques and GLP laboratory practices. Manages CDS (chromatography data system) including Empower and Chromeleon. Ensures data integrity compliance across all chromatography-related activities. Stays current with USP, BP chapters on HPLC and advances in analytical techniques.

Performs chemical and physical testing of raw materials, in-process, and finished products. Operates analytical instruments including HPLC, GC, UV-Vis, and IR spectrophotometers. Prepares reference standards, reagents, and mobile phases for analytical testing. Records test results accurately in laboratory notebooks and LIMS systems. Investigates OOS and OOT results and prepares investigation reports. Maintains calibration and qualification records for all analytical instruments. Performs microbiological testing including bioburden, sterility, and LAL testing. Ensures compliance with pharmacopoeial standards including IP, BP, and USP. Reviews analytical methods and assists in method development and validation. Manages stability testing samples and prepares stability reports. Follows GLP guidelines and maintains clean and organized laboratory workspaces. Supports internal and regulatory inspections with documentation and data. Stays updated with pharmacopoeial updates and analytical technology advances.

Manages regulatory submissions for new and existing pharmaceutical products. Prepares CTD dossiers for CDSCO, USFDA, and EMA submissions. Develops regulatory strategies for product approvals and lifecycle management. Liaises with health authorities and responds to regulatory queries. Manages product labelling, package inserts, and SmPC updates. Coordinates regulatory aspects of product launches and line extensions. Reviews and approves promotional materials for regulatory compliance. Conducts regulatory intelligence and monitors guideline changes. Manages registration renewals, variations, and post-approval changes. Trains internal teams on regulatory compliance and documentation. Oversees regulatory aspects of clinical trial authorizations. Collaborates with global regulatory teams on multi-market submissions. Ensures compliance with Schedule M, GMP, and quality standards.

Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Duties and Accountabilities: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Participate in regulatory inspections, health authority meetings, and internal audits. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Conduct structured literature reviews and contribute to scientific summaries and labelling. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Key Skills and Qualifications: Effective presentation skills with the ability to communicate complex ideas with clarity. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Critical and strategic thinking skills with the ability to translate insights into clear actions. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Sound understanding of organisational dynamics and stakeholder management in complex environments. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This is an outstanding opportunity for a motivated professional to advance their career within a reputable organisation.

Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Scope of Responsibilities: Conduct structured literature reviews and contribute to scientific summaries and labelling. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Participate in regulatory inspections, health authority meetings, and internal audits. Support collection and review of adverse event safety data from clinical and post-market sources. Competencies and Qualifications: Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Ability to work both independently and in a team-oriented, collaborative environment. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.