Regulatory Affairs Associate

**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...

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...

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...

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...

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...

**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...

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...

**(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...

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...

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). -...