Associate - Regulatory Affairs Medical Devices & Nutraceuticals

As an Associate Regulatory Affairs, your primary role will be to assist in obtaining and maintaining regulatory approvals for beauty, health, wellness, cosmetics, and food products. It is crucial to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. Your responsibilities will include preparing dossiers that are country and category-specific for domestic and international markets to ensure error-free and timely submissions according to department timelines. You will be responsible for coordinating with suppliers and vendors to maintain product master data. Additionally, you will review, prepare, submit, and coordinate with relevant regulatory bodies across countries. Resolving deficiencies and queries from customers, partners, and regulatory agencies will also be part of your role. You will assist in the development of Regulatory Affairs Standard Operating Procedures (SOPs) and ensure adherence to internal audit requirements as per Quality Management System (QMS) standards. Participating in risk-benefit analysis for regulatory compliance and identifying, planning, and implementing process improvement initiatives are also key aspects of your responsibilities. To qualify for this role, you must hold a graduate degree in Science, Engineering, or Pharmacy. A minimum of 2 years of experience in global regulatory requirements of products, processes, and procedures is required. Experience in product compliance or product stewardship is preferred. You should be able to work independently without supervision and communicate effectively, both in writing and orally, with technical and non-technical colleagues. As a problem solver, you should be able to identify issues, review related information, develop and evaluate options, and implement effective solutions. Managing parallel projects and sometimes competing deliverables to meet project delivery dates will also be part of your job scope.,