Regulatory Affairs Specialist

This role is for one of our clientsIndustry: Administrative and Support ServicesSeniority level: Mid-Senior levelMin Experience: 3 yearsLocation: India, HyderabadJobType: full-timeWe are seeking a detail-oriented and proactive

Regulatory Affairs Specialist

to join our team. This role will be responsible for preparing, compiling, and managing regulatory submissions across global markets while ensuring compliance with international standards. The ideal candidate will possess strong knowledge of regulatory frameworks and experience in Drug Master Files (DMFs), Active Substance Master Files (ASMFs), and related submissions.Key Responsibilities

Regulatory Submissions & Documentation

Prepare, compile, and review

US DMFs (Type II), EU ASMFs

, and region-specific dossiers.Develop, compile, and maintain

CTD/eCTD dossiers

for submissions to USFDA, EDQM, WHO, TGA, and other authorities.Ensure all submissions are compliant with current international regulations and internal quality standards.Manage lifecycle activities including

updates, amendments, deficiency responses, and annual reports

.

Cross-Functional Collaboration

Partner with

QA, QC, R&D, and Manufacturing teams

to gather necessary technical documentation.Review product-related data such as

stability reports, specifications, and Certificates of Analysis (COAs)

to ensure accuracy and completeness.

Audits & Compliance

Support regulatory inspections and audits conducted by authorities or clients.Coordinate timely and accurate responses to regulatory queries, observations, and compliance requirements.

Regulatory Strategy & Intelligence

Track and interpret changes in global regulatory guidelines (USFDA, EMA, ICH, WHO, etc.).Provide recommendations on submission strategies, product classification, and compliance updates.

Required Qualifications & Skills

Bachelor’s or Master’s degree in

Pharmacy, Life Sciences, or related disciplines

.

3–7 years of experience

in Regulatory Affairs, preferably within

pharmaceuticals, nutraceuticals, or herbal products

.Proven expertise in

DMF/ASMF preparation and global dossier submissions

.Strong knowledge of international regulatory frameworks (USFDA, EMA, WHO, TGA).Excellent organizational, communication, and documentation skills.Detail-oriented with the ability to manage multiple projects and meet deadlines.