13 Nov
|
Keuro Life
|
Chennai
13 Nov
Keuro Life
Chennai
Company Description Keuro Life is a healthcare-focused organization dedicated to developing safe, effective, and innovative products that improve patient outcomes and quality of life. The company emphasizes rigorous scientific standards, strong ethical practices, and robust compliance with global and local regulatory frameworks.
Keuro
Life fosters a collaborative environment where cross-functional teams work together to bring high-quality therapies and solutions to market efficiently. Professionals joining Keuro Life can expect a culture that values continuous learning, integrity, and long-term career growth.
Role Description The Senior Regulatory Affairs Specialist is a full-time, on-site role based in Chennai. This position is responsible for preparing, reviewing, and managing regulatory documentation required for product approvals and lifecycle maintenance.
Day-to-day tasks include interpreting and applying regulatory requirements, coordinating regulatory submissions, and ensuring compliance with applicable laws and guidelines in relevant markets. The role involves partnering with cross-functional teams such as R&D;, Quality, Clinical, and Marketing to support product development and post-market activities.
The specialist will also monitor regulatory changes, advise internal stakeholders on impact, and contribute to internal processes and policies that strengthen compliance and submission quality.
Qualifications
- Robust skills in regulatory documentation and regulatory submissions for healthcare or life sciences products.
- Expertise in regulatory affairs and regulatory compliance within relevant regional and international frameworks.
- Ability to interpret and apply regulatory requirements to product development, labeling, and post-market activities.
- Experience collaborating with cross-functional teams and communicating regulatory guidance clearly and effectively.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related discipline.
- Several years of experience in regulatory affairs, with a track record of successful submissions and approvals.
- Strong organizational skills, attention to detail, and ability to manage multiple projects and deadlines.
- Proficiency in English (written and spoken) and familiarity with relevant regulatory agencies and standards.
📌 Senior Regulatory Affairs Specialist (Chennai)
🏢 Keuro Life
📍 Chennai