Researches and evaluates medicinal plants for therapeutic and pharmacological potential. Develops standardized herbal extracts and conducts phytochemical profiling. Performs botanical authentication and quality testing of crude drugs. Develops and validates analytical methods for marker compounds in herbal products. Conducts in-vitro biological activity screening of plant extracts and isolates. Prepares herbal drug master files and regulatory submissions for AYUSH products. Manages raw material sourcing, authentication, and quality assessment programs. Coordinates with pharmacology teams for safety and efficacy evaluation studies. Prepares dossiers for product registration under AYUSH and international markets. Conducts literature reviews on traditional use, safety, and modern evidence. Supports product development of polyherbal, nutraceutical, and Ayurvedic products. Ensures compliance with WHO monographs and pharmacopoeial herbal standards. Stays updated with AYUSH regulations, GACP guidelines, and global herbal trends.

Leads regulatory strategy for new drug applications and product lifecycle. Manages a team of regulatory affairs executives and specialists. Oversees preparation and submission of dossiers to CDSCO and global agencies. Develops regulatory roadmaps for new products and line extensions. Reviews and approves all regulatory documents before submission. Maintains relationships with regulatory consultants and government contacts. Leads responses to major regulatory queries, show cause notices, and GMP inspections. Manages regulatory intelligence and monitors global regulatory changes. Coordinates pre-submission meetings with drug regulatory authorities. Ensures product labeling, patient information leaflets comply with regulations. Supports BD&L teams with regulatory due diligence for partnerships. Manages regulatory compliance programs and internal audit processes. Stays current with ICH Q&A guidelines, CDSCO amendments, and global reforms.

Coordinates the conduct of clinical trials at the site level. Manages patient recruitment, screening, and enrolment processes. Obtains informed consent and ensures ethical compliance in trials. Maintains accurate case report forms and study documentation. Coordinates investigator meetings and site initiation visits. Manages study drug accountability, dispensing, and reconciliation. Schedules and coordinates study visits with participants and teams. Liaises with sponsors, CROs, and ethics committees. Ensures GCP and ICH guidelines compliance throughout trial conduct. Handles adverse event reporting and safety notifications. Manages site master file and essential document maintenance. Prepares site for monitoring visits and audits by sponsors. Trains site staff on study protocols and regulatory requirements.

Position: Clinical Data Manager We invite a proactive and capable Clinical Data Manager to lead and execute within a collaborative, agile environment. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Responsibilities Include: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Conduct structured literature reviews and contribute to scientific summaries and labelling. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Support collection and review of adverse event safety data from clinical and post-market sources. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Participate in regulatory inspections, health authority meetings, and internal audits. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Skills and Qualifications: Strong communication, presentation, and interpersonal skills across all organisational levels. A structured, results-driven approach with the ability to meet defined milestones consistently. Hands-on experience with tools, software, and platforms standard to the profession. 26 years of relevant industry experience with evidence of increasing responsibility. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. 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 fosters a culture of continuous learning, development, and shared organisational accountability. Key Responsibilities: Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. 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. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. 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. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Qualifications and Requirements: Minimum 35 years of progressive professional experience in a comparable role. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Excellent verbal and written communication skills; fluency in English is essential. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Experience collaborating within cross-functional teams and matrix organisational structures. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Successful candidates will receive access to ongoing professional development and industry-leading resources.