Regulatory Affairs Consultant

3 days ago


Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

At Immuneel Therapeutics Pvt. Ltd., we are a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India.

Company Overview

We pursue, with purpose, to serve our patients by connecting within, collaborating globally and creating solutions. Our flexible, diverse, and vibrant team brings together best practices and innovations in the field of cell and gene therapy.

About the Role

This role requires strong organizational skills, a high level of attention to detail, and the ability to collaborate across cross-functional teams. The ideal candidate will play a critical role in managing and supporting regulatory submissions, ensuring compliance with global regulatory requirements, and maintaining the highest standards of operational efficiency in regulatory processes.

Main Responsibilities
  • Regulatory operations and liaison: Review and submit regulatory documents, including Test licence No C, Import licence, IND and MA applications for cell and gene therapy products to CDSCO.
  • Represent immuneel for discussions and application with DCGI office, New Delhi.
  • Submission and follow up of RCGM submissions like form C3, Form C5 and liaise with RCGM and for meeting and approvals.
Requirements

The ideal candidate should have 10+ years of experience in regulatory operations, regulatory affairs, or a related field. They should also have extensive experience in liaison with DCGI, RCGM and other regulatory offices. Additionally, they should possess strong soft skills, including excellent communication and negotiation skills, technical writing skills, and presentation skills.



  • Delhi, Delhi, India 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: Regulatory affairs leader who builds and executes regulatory...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    We're passionate about developing innovative solutions that drive patient outcomes and improve lives.Our goal is to create a world where patients have access to life-changing treatments, and we're seeking a talented professional to join our team as a Regulatory Affairs Specialist.In this role, you will be responsible for managing and supporting regulatory...


  • Delhi, Delhi, India Lyrus Full time

    Job OverviewLyrus is seeking an experienced Regulatory Affairs professional to coordinate with cross-functional teams and ensure compliance with regulatory requirements. The successful candidate will have a strong background in dossier handling, e-CTD software management, and technical document review.About the RoleThis Senior Officer/Executive Regulatory...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    At Immuneel Therapeutics Pvt. Ltd., we are pioneering the field of cell therapy and personalized immunotherapy for patients in India. As a Regulatory Affairs Specialist, you will play a critical role in managing and supporting regulatory submissions, ensuring compliance with global regulatory requirements, and maintaining the highest standards of operational...


  • Delhi, Delhi, India Vehere Full time

    Job Summary:The Director of Regulatory Affairs will lead the regulatory compliance strategy for Vehere, ensuring that all products, technologies, and services meet regulatory requirements across Indian markets. This role will involve managing regulatory submissions, advocating compliance standards, collaborating with cross-functional teams, and staying ahead...


  • Delhi, Delhi, India Vehere Full time

    Job Summary:The Director of Regulatory Affairs will lead the regulatory compliance strategy for Vehere, ensuring that all products, technologies, and services meet regulatory requirements across Indian markets. This role will involve managing regulatory submissions, advocating compliance standards, collaborating with cross-functional teams, and staying ahead...


  • Delhi, Delhi, India BeatO Full time

    We are looking for a detail-oriented Regulatory Affairs Executive to oversee compliance with ISO 13485:2016, ISO 9001:2015, and ISO 27001:2022 standards. The role involves ensuring adherence to regulatory requirements, coordinating audits, managing documentation, and supporting quality management initiatives to maintain certifications.Ensure compliance with...


  • Delhi, Delhi, India Vehere Full time

    Job Summary The Director of Regulatory Affairs will lead the regulatory compliance strategy for Vehere, ensuring that all products, technologies, and services meet regulatory requirements across Indian markets. This role will involve managing regulatory submissions, advocating compliance standards, collaborating with cross-functional teams, and staying ahead...


  • Delhi, Delhi, India Adalvo Full time

    At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we are always on target, we are AdalvoWe are looking for an enthusiastic Regulatory Affairs Specialist, CMC to join our dynamic Regulatory Affairs team. If...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    About Immuneel Therapeutics Pvt. Ltd.At Immuneel, we're pioneering a new frontier in cell therapy and personalized immunotherapy for patients in India. Our mission is to pursue excellence, serve our patients with purpose, and connect globally. We value diversity, work-life balance, and an open environment where everyone can thrive.We're looking for a...


  • Delhi, Delhi, India Adalvo Full time

    At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we arealways on target , we areAdalvo We are looking for an enthusiastic Regulatory Affairs Specialist, CMC to join our dynamic Regulatory Affairs team. If...


  • Delhi, Delhi, India Kairosoft AI Solutions Ltd Full time

    **Job Description:**Kairosoft AI Solutions Ltd. requires a highly skilled Company Secretary to manage our regulatory affairs and ensure effective interactions with regulatory bodies.**Key Responsibilities:Regulatory Compliance Management: Oversee all aspects of regulatory compliance, with a focus on SEBI regulations.Listing Obligations & Disclosure...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    About ImmuneelImmuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.comWe Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    About ImmuneelImmuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible,...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible,...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    About ImmuneelImmuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse,...


  • Delhi, Delhi, India Lyrus Full time

    Job position: Sr. Officer / Executive Regulatory AffairsEducational qualificationGraduation/post-graduation in Pharma, science or any life scienceFunction/departmentRegulatory affairsExpected year of experience4+ yearsMandatory technical skill and experience1.    At least 4 years of experience in Regulatory Affairs2.    Hands on dossier handling (M1...


  • Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

    At Immuneel Therapeutics Pvt. Ltd., we are pioneering a new era in cell therapy and personalized immunotherapy for patients in India.We are seeking an experienced Regulatory Affairs Manager to join our team and contribute to our mission of delivering high-quality engineered cell therapies.The ideal candidate will play a critical role in managing and...