Regulatory Affairs Associate

2 days ago


Remote, India Parexel Full time

**Regulatory Affairs Associate**
- Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.
- Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
- Experience in handling CMC related health authority queries
- Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
- Preparation of documentation for different types of Variation procedures like Super grouping,
- Grouping and Work-sharing to the Marketing Authorizations.
- Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
- Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions
- Liaise closely with cross-functional members with aligned product responsibilities.
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
- Working experience in Regulatory Information Management Systems like Veeva Vault.
- Strong communications skills and ability to guide and mentor team members.

Ability to work independently.

LI-REMOTE

Back to nav



  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Medidee Full time

    Hyderabad **EMAIL** I **Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India** Diagnostics compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

  • Medical Affairs

    4 days ago


    Remote, India Mango Sciencies Full time ₹ 20,00,000 - ₹ 30,00,000 per year

    Director, Medical Affairs (Remote)Join a rapidly growing HealthTech/Life Sciences company focused on revolutionizing Oncology care and expanding access to Precision Medicine in global emerging markets. This critical remote leadership role requires an expert to drive our medical strategy, specifically by leveraging AI-powered Real-World Evidence (RWE) and...


  • Remote, India Satyam Group Full time

    Responsibilities: - Receive and process adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials. - Conduct initial assessment of reported adverse events to determine seriousness, expectedness, and causality. - Enter adverse event data into safety databases accurately and in a timely manner, ensuring...

  • Clinical Research

    1 week ago


    Remote, India IPR LEARNING INSTITUTE Full time

    **Responsibilities**: - Assist in the planning, execution, and monitoring of clinical research studies. - Ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. - Monitor and report adverse drug reactions (ADRs) and other pharmacovigilance activities. - Conduct literature reviews and safety signal assessments. - Maintain...


  • Remote, India CanSat Consulting Inc. and SIAS Solutions Inc. Full time ₹ 2,80,000 - ₹ 4,80,000 per year

    Job Title: Compliance and Quality AssociateLocation: Remote working from IndiaTimings: Monday to Friday (6:00 PM to 3:00 AM IST/ 8:30 PM to 5:30 PM ET) with every second Saturday working. Hours might vary depending on the Time Zone. Extended hours may be required to work, depending on the workload.Salary: INR 35,000 to 40,000BusinessOur client is a...


  • Remote, India Kateric Full time

    **(India)**: Looking for experienced regulatory writers **As we are expanding our team, we are thrilled to announce that we are looking for experienced Indian regulatory writers to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a full-time, remote, salaried...

  • Cyber lawyer

    2 weeks ago


    Remote, India SP transaction hub technology Pvt. Ltd Full time ₹ 90,000 - ₹ 6,25,000 per year

    We are seeking a proactive and detail-oriented Legal Officer with specialized expertise in Cyber Law, Corporate Legal Affairs, and the fintech/payments regulatory environment. The ideal candidate will be responsible for overseeing legal operations, managing regulatory risks, and ensuring the organization is compliant with applicable laws, including those...

  • Pharmacist

    2 weeks ago


    Remote, India Hawkz International Full time

    Core Responsibilities: - **Formulation and Development**:Lead the creation and development of new pharmaceutical products, ensuring they meet regulatory and company standards. - **Manufacturing Oversight**:Supervise the production process, from planning to completion, ensuring quality control and compliance with Good Manufacturing Practices (GMP). -...