Weekday (YC W21)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