ASSISTANT MANAGER / MANAGER REGULATORY AFFAIRS

Company Description CliniLaunch Research Institute is an advanced clinical research and professional training center dedicated to developing industry-ready talent for the clinical research sector. The institute focuses on elevating graduates from Pharmacy, Life Sciences, Medicine, and Paramedical disciplines into rewarding careers in clinical research. Through long-standing industry partnerships and tie-ups, CliniLaunch connects aspiring professionals with suitable opportunities. CliniLaunch has pioneered specialized clinical research programs and has successfully trained a large number of learners, making it a significant contributor to the clinical research workforce. The institute is committed to bridging the gap between academic knowledge and practical industry requirements.
Role Description The Assistant Manager / Manager – Regulatory Affairs is a full-time, on-site position based in Dehradun. The role involves preparing, reviewing, and submitting regulatory documents and dossiers in compliance with national and international guidelines. Responsibilities include coordinating with internal teams and external stakeholders to ensure timely regulatory approvals, maintaining accurate regulatory records, and monitoring changes in relevant regulations and guidelines. The role also covers drafting standard operating procedures related to regulatory affairs, supporting inspections and audits, and providing regulatory guidance to project teams. The Manager will collaborate closely with clinical, quality, and training departments to support the institute's programs and industry partnerships from a regulatory perspective.
Qualifications

• Strong knowledge of regulatory guidelines and processes related to clinical research, pharmaceuticals, or life sciences.
• Ability to prepare, review, and manage regulatory documents, submissions, and compliance reports.
• Proficiency in documentation, record-keeping, and use of standard office and regulatory tools/software.
• Excellent written and verbal communication skills, with the ability to draft clear regulatory correspondence and SOPs.
• Sound analytical and problem-solving skills, including the ability to interpret and apply regulatory requirements.
• Experience in coordinating with cross-functional teams and external regulatory bodies or ethics committees.
• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, or a related field; specialized training in clinical research or regulatory affairs is an advantage.
• Prior experience in regulatory affairs or clinical research is preferred; leadership experience is beneficial for the Manager level.
• Ability to work diligently on-site in Dehradun, manage multiple projects, and meet deadlines in a structured manner.