Develops nutraceutical, dietary supplement, and functional food formulations. Conducts ingredient screening for efficacy, safety, and bioavailability. Designs stability studies and shelf-life evaluation for nutraceutical products. Develops sensory evaluation protocols for taste, texture, and palatability. Ensures compliance with FSSAI regulations for health supplements and foods. Coordinates claims substantiation with clinical data and evidence reviews. Manages ingredient qualification, safety assessment, and GRAS evaluation. Supports product registration and regulatory filing with FSSAI and APEDA. Develops packaging specifications and storage recommendations for products. Coordinates with marketing for product differentiation and claim messaging. Conducts competitive benchmarking of nutraceutical products in the market. Manages CMO relationships for nutraceutical contract manufacturing activities. Stays updated with FSSAI updates, global nutraceutical trends, and novel ingredients.

Leads quality assurance function for one or more manufacturing sites. Responsible for GMP compliance across all manufacturing and support functions. Manages preparation and submission of responses to regulatory authority observations. Oversees change control, deviation management, and CAPA closure programs. Reviews and approves all critical quality documents and batch release decisions. Leads regulatory inspections including US-FDA, EU-GMP, and WHO pre-qualification. Develops and implements quality improvement initiatives across the site. Manages vendor qualification programs and third-party manufacturing compliance. Ensures validation lifecycle management for equipment, processes, and cleaning. Prepares site quality metrics and KPIs for management review meetings. Manages annual product quality review and product quality management systems. Mentors QA executives and builds team capability in quality management. Stays current with regulatory guidances, warning letters, and inspection trends.

Monitors and evaluates adverse drug reactions for pharmaceutical products. Collects, processes, and reports individual case safety reports (ICSRs). Prepares periodic safety update reports (PSURs) per regulatory timelines. Conducts signal detection and benefit-risk assessment for products. Ensures compliance with CDSCO, EMA, and FDA pharmacovigilance guidelines. Manages pharmacovigilance database including Oracle Argus or Veeva Vault. Reviews scientific literature for safety signals and publications. Collaborates with medical affairs and regulatory teams on safety labelling. Supports risk management plan development and implementation. Trains field teams on adverse event reporting procedures. Handles health authority queries related to drug safety. Participates in global safety committee meetings and discussions. Prepares product safety summaries for regulatory submissions.

Position: Clinical Data Manager Our organisation invites applications from accomplished professionals for the role of Clinical Data Manager. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Main Accountabilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Provide clinical site training on data collection standards and regulatory requirements. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Essential Skills and Experience: Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Collaborative, proactive, and able to operate effectively with minimal supervision. Strong project management capabilities with experience in agile or structured methodologies. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Superior writing and communication skills with experience preparing executive-level documents. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. The organisation provides a comprehensive benefits package and excellent career advancement opportunities for the right candidate.

Position: Clinical Data Manager We are looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Responsibilities Include: Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Support collection and review of adverse event safety data from clinical and post-market sources. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Ensure all cases are coded and processed per MedDRA and applicable global standards. Conduct structured literature reviews and contribute to scientific summaries and labelling. Skills and Qualifications: Hands-on experience with tools, software, and platforms standard to the profession. Strong communication, presentation, and interpersonal skills across all organisational levels. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Willingness to travel, adapt, and take on additional responsibilities as the business demands. 26 years of relevant industry experience with evidence of increasing responsibility. A structured, results-driven approach with the ability to meet defined milestones consistently. 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.