Drugs Regulatory Affairs EXPORT Manager

Company Description

Synokem Pharmaceuticals Ltd, with over 40 years of experience, is a leading pharmaceutical manufacturer and exporter based in India. The company operates three manufacturing plants in Haridwar and manages its corporate operations from New Delhi. Synokem has four key business verticals: contract manufacturing for major clients, self-marketing of branded products in India, exports to 30 countries, and government/institutional supplies. Synokem is recognized for its innovation and global contribution, including the development of life-saving drugs like Favipiravir and Molnupiravir during the COVID pandemic. The company is also committed to social responsibility through the Synokem Foundation, supporting initiatives in women's healthcare, child education, and the welfare of visually impaired individuals and senior citizens.

Role Description

We are seeking a dedicated Drugs Regulatory Affairs EXPORT Manager to join our team in New Delhi. This is a full-time, on-site role. The manager will handle regulatory submissions and ensure compliance with regulatory requirements for exporting pharmaceutical products in ROW countries & EU experience is must , person resonsible review of CMC & handle query resolution to be raised by MOH . He must experience of EU region . overseeing international regulatory submissions, ensuring adherence to quality systems, and liaising with global regulatory authorities. The ideal candidate will ensure that all processes meet export standards and regulatory guidelines.

Qualifications

• Strong knowledge of Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs.
• Proficiency in the preparation and management of Regulatory Submissions for export markets.
• Understanding of Quality Systems and their implementation in regulatory processes.
• Excellent organizational and communication skills with attention to detail.
• Experience in international pharmaceutical regulatory activities is an asset.
• At minimum, a Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• Knowledge of global regulatory guidelines and export regulations is highly desirable.