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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Weekday

3 years

3 - 8 Lacs

hyderābād

Posted:4 hours ago| Platform: GlassDoor logo

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Skills Required

support compliance regulations qc manufacturing data stability reports analysis audits strategy strategies communication documentation

Work Mode

On-site

Job Type

Full Time

Job Description

This role is for one of our clients

Industry: Administrative and Support Services

Seniority level: Mid-Senior level

Min Experience: 3 years

Location: India, Hyderabad

JobType: full-time

We 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.

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Regulatory Affairs Specialist