Company Description Charak Pharma Pvt. Ltd., part of the Charak group established in 1947, is a leading herbal healthcare organization with a strong focus on global exports. The company transforms traditional herbal knowledge into modern, standardized products backed by scientific evidence of safety and efficacy.

Charak offers more than 50 herbal supplements addressing diverse health needs such as women’s health, diabetes, respiratory care, oral hygiene, and digestive wellness, with several brands recognized as category leaders in India. Quality is supported by ISO 9001:2000 certification, WHO-GMP certified manufacturing, stringent quality checks, clinical studies, and comprehensive technical documentation. Charak has an expanding international presence across major continents, including markets in Europe, Asia, Africa, and North America.

Role Description The Regulatory Affairs Manager is a full-time, in office role based in Mumbai, responsible for overseeing regulatory compliance for Charak Pharma’s herbal healthcare products in domestic and international markets. This role includes preparing, reviewing, and submitting dossiers and registration documents, ensuring alignment with local and global regulatory requirements, and maintaining up-to-date knowledge of relevant regulations and guidelines.

The Regulatory Affairs

Manager will coordinate with R&D;, quality, manufacturing, and marketing teams to ensure product labels, claims, and promotional materials meet regulatory standards. Daily activities involve managing communications with regulatory authorities and external partners, tracking approval timelines,



maintaining regulatory databases and documentation, and supporting audits and inspections. The role also contributes to regulatory strategy for new product development and market expansion, identifying regulatory risks and proposing mitigation plans.

Qualifications

- Strong regulatory affairs expertise, including experience with dossier preparation, product registration, and lifecycle management for pharmaceuticals, herbal or nutraceutical products.
- Solid understanding of national and international regulatory frameworks, guidelines, and standards (e.g., WHO-GMP, ISO, and country-specific regulatory requirements).
- Proficiency in documentation, technical writing, and data review, with high attention to detail and accuracy.
- Effective cross-functional collaboration skills, with the ability to coordinate among R&D;, quality, manufacturing, and commercial teams.
- Excellent analytical, problem-solving, and decision-making abilities to assess regulatory risks and develop practical solutions.
- Strong written and verbal communication skills for clear interaction with regulatory authorities, partners, and internal stakeholders.
- Ability to manage multiple projects and timelines, prioritize tasks, and work independently in a structured, organized manner.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related field; specialized training in regulatory affairs is an advantage.
- Prior experience in regulatory affairs within pharmaceutical, herbal, or nutraceutical industries; exposure to international registrations is highly beneficial.

📌 Regulatory Affairs Manager (Mumbai)
🏢 Charak Pharma
📍 Mumbai