Develops global regulatory strategies for new molecular entities and biosimilars. Leads interactions with FDA, EMA, and international regulatory agencies. Guides multidisciplinary teams on regulatory pathway selection and requirements. Prepares regulatory briefing documents and pre-submission meeting requests. Reviews and approves regulatory submissions for quality, safety, and efficacy. Manages priority review, fast track, and orphan drug designation applications. Coordinates regulatory activities across global markets for portfolio products. Provides regulatory guidance for in-licensing, BD&L, and M&A activities. Leads regulatory due diligence for new asset acquisitions and partnerships. Represents regulatory function at executive committees and governance boards. Manages relationships with regulatory consultants and external scientific advisors. Develops regulatory training programs for scientists and development teams. Stays current with global regulatory reforms, NME guidances, and agency policies.

Develops and optimizes manufacturing processes for pharmaceutical drug products. Conducts process characterization studies using statistical and risk-based tools. Scales up formulations from laboratory to pilot and commercial manufacturing scale. Develops process validation protocols, reports, and process control strategies. Applies Quality by Design (QbD) principles in process development activities. Identifies critical quality attributes (CQAs) and critical process parameters (CPPs). Uses design of experiments (DoE) to optimize processing conditions systematically. Supports technology transfer by preparing process descriptions and batch records. Investigates manufacturing failures and recommends process improvements. Collaborates with analytical development and QA teams on product development. Prepares CMC sections for ANDA/NDA regulatory submissions. Manages pilot plant and manufacturing scale equipment qualification activities. Stays updated with ICH Q8, Q9, Q10, Q11 guidelines and validation guidance.

Assesses and treats patients with musculoskeletal, neurological, and respiratory conditions. Develops individualized physiotherapy treatment plans and goals. Administers electrotherapy, manual therapy, and exercise interventions. Provides post-operative rehabilitation for orthopaedic and cardiac patients. Conducts neurological rehabilitation for stroke and spinal cord patients. Manages ICU physiotherapy including chest care and early mobilization. Educates patients on home exercise programs and self-management. Assesses functional abilities and develops return-to-work plans. Collaborates with physicians and occupational therapists for holistic care. Documents treatment progress and adjusts plans accordingly. Trains physiotherapy assistants and student physiotherapists. Participates in clinical research and evidence-based practice updates. Ensures compliance with IAP and physiotherapy ethical standards.

Position: Clinical Research Manager An exciting career opportunity exists for a motivated Clinical Research Manager to advance their professional journey. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Role Responsibilities: Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Develop SOPs, work instructions, and training materials for clinical operations teams. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Education and Experience Requirements: Strong analytical and problem-solving skills with the ability to navigate complex challenges. Excellent verbal and written communication skills; fluency in English is essential. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. 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 Manager Our organisation is looking for an ambitious Clinical Manager committed to quality outcomes and sustained growth. This is an excellent opportunity for professionals who value structured career advancement and meaningful impact. Key Deliverables and Responsibilities: Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Provide clinical site training on data collection standards and regulatory requirements. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Professional Requirements: Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Strong communication, presentation, and interpersonal skills across all organisational levels. 26 years of relevant industry experience with evidence of increasing responsibility. Willingness to travel, adapt, and take on additional responsibilities as the business demands. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. 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. We look forward to welcoming a driven professional who shares our commitment to excellence and sustained impact.