Assistant Manager - Regulatory Affairs

Why This Role Matters
The Assistant Manager – Regulatory Affairs plays an important role in supporting global pharmaceutical regulatory submissions and ensuring compliance with international guidelines. This position contributes to successful product approvals in the EU and UK markets by managing CMC documentation, regulatory submissions, and lifecycle management activities.

Job Description
The Assistant Manager – Regulatory Affairs will handle regulatory documentation, CMC review, and submission activities for EU and UK markets. The role involves preparing CTD dossiers, managing variations and renewals, coordinating with cross-functional teams, and ensuring compliance with EMA and MHRA regulatory standards.

Key Features of the Role
• Opportunity to work on EU and UK regulatory submissions
• Exposure to global pharmaceutical regulatory strategies and compliance
• Involvement in CTD dossier preparation and lifecycle management
• Collaboration with R&D, QA, QC, and manufacturing teams
• Professional growth in international regulatory affairs

Responsibilities
• Conduct CMC reviews of technical documentation for regulatory submissions in EU and UK markets
• Perform gap analysis and remediation for Module 3 (CMC) documentation
• Develop regulatory strategies, timelines, and processes for Marketing Authorization submissions
• Prepare and compile CTD dossiers, variations, and renewals for regulatory filings
• Ensure documentation compliance with EMA and MHRA regulatory guidelines
• Review submission documents for consistency, accuracy, and regulatory alignment
• Collaborate with internal departments and external stakeholders for regulatory submissions
• Monitor updates from regulatory authorities and maintain knowledge of current guidelines
• Support efficient communication and coordination across project teams

Required Qualifications

Educational Requirements:
• Master’s Degree in Pharmacy (M.Pharm or equivalent)

Experience and Skills:
• 4–6 years of experience in Regulatory Affairs within the pharmaceutical industry
• Experience with EU and/or UK regulatory submissions
• Strong knowledge of CMC documentation and CTD dossier preparation
• Understanding of EMA and MHRA regulatory requirements
• Excellent analytical and technical data interpretation skills
• Strong communication, negotiation, and presentation abilities
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
• Experience with document management systems and regulatory tools
• Ability to work collaboratively in a fast-paced, team-oriented environment

Salary Insights:
• Salary details were not specified in the job posting

Company Overview
DDReg Pharma is a regulatory consulting and pharmaceutical services company specializing in global regulatory strategy, dossier preparation, and submission management. The organization supports pharmaceutical companies in obtaining regulatory approvals across international markets including the US, EU, and other global regions.

FAQs
• What qualification is required for this role?
Candidates should have a Master’s degree in Pharmacy or an equivalent qualification.

• How much experience is required?
Applicants should have approximately 4–6 years of experience in regulatory affairs.

• Which markets will the candidate work with?
The role focuses on regulatory submissions for the EU and UK markets.

• Where is the job located?
The position is based in Gurgaon, Haryana, India.

Application Tips
• Highlight experience with EU and UK regulatory submissions
• Mention expertise in CTD dossier preparation and CMC documentation
• Showcase knowledge of EMA and MHRA regulatory guidelines
• Emphasize analytical skills and regulatory documentation experience
• Include examples of regulatory strategies or submissions handled in previous roles