Manages IT infrastructure, systems, and applications for pharmaceutical operations. Oversees ERP system (SAP) administration, upgrades, and user support. Manages computerized system validation (CSV) for GxP-regulated IT applications. Ensures data integrity compliance across all manufacturing and quality IT systems. Manages LIMS, MES, DMS, and other GxP application systems at the site. Leads IT governance including change management, ITSM, and service delivery. Manages cybersecurity program and ensures IT compliance with information security policies. Coordinates with global IT teams on system rollouts and infrastructure upgrades. Manages software license compliance and IT procurement activities. Supports regulatory inspection teams with IT system documentation and access. Manages IT helpdesk and ensures SLAs for system availability and support. Evaluates new pharma IT technologies including IoT, AI, and digital manufacturing. Stays updated with 21 CFR Part 11, GAMP 5, and digital transformation in pharma.

Leads quality control laboratory operations across raw material, in-process, and finished goods. Manages a team of QC analysts, scientists, and laboratory technicians. Oversees method development, validation, and transfer for all analytical methods. Ensures laboratory equipment qualification, calibration, and maintenance programs. Reviews and approves analytical data, QC release, and stability protocols. Manages OOS/OOT investigations and ensures timely resolution. Leads laboratory audit readiness and manages responses to inspector observations. Oversees reference standard management and reagent control programs. Ensures LIMS system integrity and data integrity compliance across laboratory. Manages stability study programs and prepares annual stability reports. Coordinates with production, QA, and procurement teams on quality matters. Prepares QC section for regulatory submissions and product dossiers. Stays current with USP, BP, ICH Q2R1, and regulatory data integrity guidance.

Develops and executes medical affairs strategy for therapy areas. Provides scientific and clinical support to internal and external stakeholders. Manages KOL (Key Opinion Leader) engagement and development plans. Reviews and approves promotional and medical content for accuracy. Supports clinical trial programs and investigator-initiated studies. Responds to unsolicited medical information requests from HCPs. Develops medical education programs for healthcare professionals. Represents company at medical conferences and symposia. Collaborates with market access and HEOR teams on value dossiers. Conducts advisory board meetings with therapeutic area experts. Manages medical information database and scientific content library. Ensures all medical communications comply with regulatory standards. Stays updated with therapy area scientific developments and publications.

Position: Clinical Data Manager We are seeking a highly qualified and motivated Clinical Data Manager to join our dynamic and growing team. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Core Responsibilities: Participate in regulatory inspections, health authority meetings, and internal audits. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Ensure all cases are coded and processed per MedDRA and applicable global standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Support collection and review of adverse event safety data from clinical and post-market sources. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Minimum Qualifications: Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Collaborative, proactive, and able to operate effectively with minimal supervision. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Strong project management capabilities with experience in agile or structured methodologies. 4+ years of experience with a demonstrated track record of growth and professional impact. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We are committed to fostering an inclusive workplace and welcome applications from candidates of all backgrounds.

Position: Clinical Data Manager We are looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Key Responsibilities: Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. 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. Support collection and review of adverse event safety data from clinical and post-market sources. Ensure all cases are coded and processed per MedDRA and applicable global standards. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Qualifications and Requirements: A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Excellent verbal and written communication skills; fluency in English is essential. High degree of professionalism, integrity, and alignment with organisational values. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. 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.