
Regulatory Affairs Specialist
14 hours ago
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.
37 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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