Regulatory Affairs Executive
Intrinseque HealthCompany Description Intrinseque Health is a global clinical development support organization founded and led by drug development industry professionals. The company is EN ISO 13485, ISO 9001, ISO 27001 and GDPMDS certified, and supports biopharmaceutical, biotechnology, and drug development companies throughout their clinical development programs. Intrinseque Health specializes in building robust, cost-effective clinical supply chain strategies that ensure timely delivery, installation, calibration, and training for medical devices, equipment, and ancillary supplies at trial sites. With a strong focus on addressing region-specific regulatory and logistical challenges, the organization provides project management-based solutions designed to support the full life cycle of clinical trials. Intrinseque Health engages with clients early in the clinical development process to align supply strategies with study timelines and compliance needs.
Role Description The Regulatory Affairs Executive is a full-time role based in Delhi, India, with a hybrid work arrangement that allows some work from home. This role is responsible for preparing, reviewing, and maintaining regulatory documentation and dossiers to support product registrations and clinical development activities. The executive will interpret and apply relevant regulatory requirements, support regulatory submissions, and ensure ongoing regulatory compliance across markets. Day-to-day tasks include coordinating with cross-functional teams, tracking regulatory timelines, responding to authority queries, and maintaining accurate records and databases. The role also involves supporting internal audits, contributing to process improvements, and assisting in regulatory strategy discussions for clinical trials and related products.
Qualifications
Role Description The Regulatory Affairs Executive is a full-time role based in Delhi, India, with a hybrid work arrangement that allows some work from home. This role is responsible for preparing, reviewing, and maintaining regulatory documentation and dossiers to support product registrations and clinical development activities. The executive will interpret and apply relevant regulatory requirements, support regulatory submissions, and ensure ongoing regulatory compliance across markets. Day-to-day tasks include coordinating with cross-functional teams, tracking regulatory timelines, responding to authority queries, and maintaining accurate records and databases. The role also involves supporting internal audits, contributing to process improvements, and assisting in regulatory strategy discussions for clinical trials and related products.
Qualifications
- Strong skills in Regulatory Documentation and Dossier Preparation, with the ability to compile, review, and organize submission-ready materials.
- Knowledge of Regulatory Requirements and Regulatory Compliance, including understanding guidelines, standards, and local/global regulatory pathways.
- Hands-on experience in Regulatory Affairs, preferably within clinical development, pharmaceuticals, biotechnology, or medical devices.
- Excellent written and verbal communication skills, with attention to detail and accuracy in technical and regulatory writing.
- Ability to work collaboratively with cross-functional teams and manage multiple projects and deadlines in a structured manner.
- Proficiency with MS Office and regulatory tracking tools or databases.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- Prior experience in clinical trial regulatory support, quality systems, or ISO-regulated environments is an advantage.