Regulatory Affairs Specialist CMC & ANDA Submissions

Why This Role Matters
The Regulatory Affairs Specialist plays a key role in ensuring pharmaceutical products meet regulatory requirements for global markets. The role supports regulatory submissions through detailed review of CMC technical documentation, preparation of ANDA filings, and ensuring compliance with regulatory guidelines, particularly for the US pharmaceutical market.

Job Description
The Regulatory Affairs Specialist will handle regulatory documentation review, support ANDA filing processes, and ensure regulatory submissions meet international compliance standards. The position involves collaborating with internal teams and stakeholders to maintain regulatory quality, prepare submission documents, and support successful regulatory approvals.

Key Features of the Role
• Opportunity to work on regulatory submissions for the US pharmaceutical market
• Exposure to ANDA, 505(b)(1), and 505(b)(2) filings
• Involvement in CMC documentation review and regulatory strategy development
• Collaboration with regulatory and cross-functional teams
• Professional growth in pharmaceutical regulatory affairs

Responsibilities
• Conduct CMC review of technical documentation for regulatory filings
• Perform gap analysis and remediation activities for Module 3 (CMC) documentation
• Develop and implement regulatory strategies and timelines for ANDA approvals
• Prepare and compile regulatory submissions including ANDAs, amendments, supplements, and annual reports
• Ensure regulatory documents meet applicable guidelines and quality standards
• Review submission documents for internal consistency and compliance with regulatory requirements
• Collaborate with internal teams and external stakeholders for regulatory activities
• Monitor regulatory updates and maintain knowledge of international regulatory guidelines
• Support communication and coordination to ensure efficient regulatory operations

Required Qualifications

Educational Requirements:
• Master’s Degree in Pharmacy or a related pharmaceutical discipline

Experience and Skills:
• 4–6 years of experience in regulatory affairs within the pharmaceutical industry
• Strong knowledge of US regulatory guidelines and submission processes
• Experience with ANDA filings and CMC documentation review
• Excellent technical data interpretation and analytical abilities
• Strong written and verbal communication skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Experience with document management systems and regulatory tools
• Ability to work effectively in a team-oriented environment

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

Company Overview
DDReg Pharma is a regulatory consulting organization that provides regulatory affairs services to pharmaceutical companies worldwide. The company supports global pharmaceutical development through regulatory strategy, dossier preparation, and compliance solutions for international markets including the US, EU, and other regulatory regions.

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

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

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

• What type of regulatory work will be involved?
The role involves ANDA submissions, CMC documentation review, and regulatory strategy development for pharmaceutical products.

Application Tips
• Highlight experience with ANDA submissions and CMC documentation
• Mention knowledge of USFDA regulatory guidelines and pharmaceutical regulatory processes
• Showcase experience in dossier preparation and regulatory compliance
• Emphasize analytical and documentation skills in regulatory work
• Include proficiency with regulatory documentation tools and systems in your resume