Regulatory Affairs Specialist

This role is for one of the Weekday's clients

Salary range: Rs 600000 - Rs 800000 (ie INR 6 - 8 LPA)

Min Experience: 1 years

Location: Mumbai

JobType: full-time

Key Responsibilities:

• Manage the registration process of Pharmaceutical, Nutraceutical, and Cosmetic products across international markets including ROW, MENA, SEA, and LATAM regions.
• Possess practical experience with ACTD, CTD, and eCTD dossier formats.
• Prepare, review, and submit dossiers to distributors in accordance with MOH guidelines.
• Collaborate with suppliers and regulatory teams of distributors for document review, compilation, and submission processes.
• Prepare, gather, and review registration documents, addressing any queries that arise.
• Work closely with internal departments to ensure timely submission of regulatory documents.
• Maintain regulatory budget sheets and keep accurate records of product registrations.
• Develop policies and standard operating procedures (SOPs) from a Quality standpoint.
• Create and approve labeling and artwork complying with country-specific requirements for both domestic and export products.

Education & Experience:

• Bachelor’s degree in Pharmacy (B. Pharm) preferred, or any Science graduate.
• 1 to 3 years of experience in international regulatory registrations.
• Immediate joiners will be given preference.
• Strong written and verbal communication skills in English.
• Self-motivated individual with high energy and a strong sense of ownership.

Skills

Dossier Preparation

MOH Guidelines

Document Registration