Regulatory Affairs

3 days ago

Delhi, Delhi, India vueverse. Full time

Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.Contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries .Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.Utilize Veeva Vault RIM to track queries and manage submission workflows.Review technical documents from manufacturing sites, including:SpecificationsBatch Manufacturing RecordsProcess & Analytical ValidationsBatch Analysis DataStability DataExperience Requirement:3+ years of experience in managing Initial submissions , Variations , and full LCM (Lifecycle management) deliverables for the global markets.Must have experience with Veeva Vault RIMProficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ ANZ/Other countries.Review of technical documents from manufacturing sites like of Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc. required for compilation of dossier sections/Variations.Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other countries (Module 2 & 3).Experience in providing Regulatory strategies/ Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.Compilation and submission of Variations/ supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.

  • Regulatory Affairs Specialist

    3 days ago

    Delhi, Delhi, India beBeeEODB Full time ₹ 8,00,000 - ₹ 12,00,000

    Regulatory Affairs SpecialistThis role involves collaborating with industry members to gather inputs on regulatory challenges and leading the development of policy notes and white papers to improve the business environment in India.The position requires identifying cross-cutting industry-wide regulatory bottlenecks through analysis of member inputs,...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Delhi, Delhi, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 24,50,000

    Job Title:Senior Regulatory Affairs Specialist

  • Senior Regulatory Affairs Specialist

    3 days ago

    Delhi, Delhi, India vueverse. Full time

    Key Responsibilities :Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing .Oversee compilation and submission of Annual Reports , amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and...

  • Manager - Regulatory Affairs

    1 week ago

    Delhi, Delhi, India Tata Play Ltd Full time

    ROLE SUMMARY Ensure Regulatory compliances and handle Government Affairs KEY DUTIES AND RESPONSIBILITIES Legal expertise in Media & Entertainment industry. We prefer a person with experience in Broadcasting sector or who has worked with a Law firm handling Broadcasting issues. Interact and be a bridge between Tata Play and TRAI, MIB, DoT, Industry bodies...

  • Manager - Regulatory Affairs - Medical Devices

    2 weeks ago

    Delhi, Delhi, India WhiteCrow Research Full time

    About are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our clients in-house our clientOur client...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Delhi, Delhi, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

    Regulatory Affairs SpecialistJob Description:We are seeking a detail-oriented and skilled professional to join our dynamic team in Delhi. The ideal candidate will be responsible for supporting the preparation, compilation, review, and submission of high-quality regulatory dossiers for various product types in accordance with regulatory requirements.Key...

  • Corporate Affairs Manager

    1 day ago

    Delhi, Delhi, India MKU Full time

    Job ObjectiveTo device Government Defence Business Development and Corporate Affairs efforts. This role involves building and maintaining strategic relationships at all levels with government stakeholders, defense agencies, and industry partners, with a focus on driving growth in the defense sector. Identify business opportunities, managing proposals and...

  • Head of Regulatory Compliance

    1 day ago

    Delhi, Delhi, India beBeeNutrition Full time US$ 60,000 - US$ 85,000

    Senior Regulatory Affairs Professional">The role of the Senior Regulatory Affairs Specialist is instrumental in driving the mission to represent and support the food and beverage industry across Asia. This specialist will be responsible for monitoring regulatory developments, providing expert guidance on health and nutrition policies, and supporting...

  • Corporate Affairs Manager

    3 weeks ago

    Delhi, Delhi, India MKU Full time

    Job ObjectiveTo device Government Defence Business Development and Corporate Affairs efforts.This role involves building and maintaining strategic relationships at all levels with government stakeholders, defense agencies, and industry partners, with a focus on driving growth in the defense sector.Identify business opportunities, managing proposals and bids,...

  • Head of Legal Affairs

    3 weeks ago

    Delhi, Delhi, India Pathways World School Full time

    Company : RPJ Holdings (P) Ltd (promoter of Pathways World School, Gurgaon) Job Title : Head of Legal and Corporate Affairs Location : Corporate Office on Main MG Road, Radisson Commercial Tower, New Delhi Reports To : CFO and Promoter Directors Requirement : We are seeking an experienced and strategic Head of Legal and Corporate Affairs to lead the...