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The Regulatory Affairs professional would be responsible for handling dossiers for new products including biosimilars, innovators, and complex generics in India.
The Head of Regulatory Affairs - India will lead regulatory strategy and compliance efforts to ensure successful registration, approval, and lifecycle management of medical devices in alignment with both national and international standards. This senior role requires an experienced leader to manage regulatory submissions, engage with authorities like CDSCO, and drive cross-functional collaboration to support innovation, quality, and business objectives.
1. Primary liaison for quality system management and regulatory affairs, interfacing with external (regulatory agencies, customers) and internal stakeholders.2. Ensure adherence to QMS policies and regulatory standards, including ISO 13485 and FDA guidelines.
We are seeking a meticulous and dedicated Regulatory Affairs and Quality professional to ensure our pharmaceutical products meet regulatory and quality standards. The successful candidate will be responsible for creating and maintaining quality assurance documentation, as well as working closely with regulatory bodies.
We are seeking an Internal Classification professional with a background in Life Sciences, specifically Medical Devices, to join our team in Bangalore. The ideal candidate should be skilled in the classification with dual exposure in regulations.
As the Quality & Regulatory Leader, you will be instrumental in establishing and managing the Quality & Regulatory Affairs function for new manufacturing plant in implant space in India. This role offers the rare opportunity to build processes, systems, and a team from the ground up and liase with our international team.
We are seeking an attentive and analytical candidate for the role of Incoming and Process Quality within the Quality Department. This role involves ensuring the quality of incoming raw materials and monitoring the manufacturing process within the Engineering & Manufacturing department.
The Head Administration and Security will oversee facilities management, ensuring operational efficiency and security compliance within the organisation. This role in Mumbai requires a proactive approach to managing resources, security protocols, and administrative functions.
The Global BD Head will be responsible for driving growth by managing strategic customer accounts, developing new business opportunities, and building long-term relationships within the medical devices sector. The role requires expertise in account planning, sales forecasting, pricing strategy, and contract negotiations, with a strong grasp of medical device industry standards and certifications (e.g., ISO 13485, FDA, CE).
Lead CDMO strategy by identifying, evaluating, and managing contract manufacturers to ensure quality, compliance, and timely production of generics. Collaborate across regulatory, R&D, and logistics teams to optimize the supply chain, ensure regulatory adherence, and mitigate outsourcing risks.
The 'Head of Manufacturing' role is a strategic position, requiring an individual capable of leading multiple plants across the country. The successful candidate will be responsible for implementing manufacturing excellence and continuous improvements for all the plants.
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