Position: Regulatory Consultant / Senior Regulatory Consultant– CMC

Location: Hybrid (80 % remote, 20 % In office)

Reports To: Manager or above, Regulatory Affairs

Company Overview
CONTINUUM is a contract research organization offering Pharmacovigilance, Regulatory,
Evidence Evaluation and Technology Solutions, which are phase dependent. These verticals
cover planning, launch and lifecycle management of Pharmaceutical, Consumer products and
Medical devices.

Functional Responsibilities
• Work with global clients on regulatory filing projects for USFDA, EMA, MHRA, APAC,
Canada etc. The key delivery areas include Pre and Post approval CMC authoring,
preparation, and submission
• Scientific writing, review, and compilation of submission documents like quality overall
summary (module 2), CMC quality – drug product, drug substance and regional
information (module 3)
• Independently author and/or coordinate CMC activities for recent registrations, post
approval changes (minor, moderate and major), renewals, annual reports, and line
extensions to meet filing requirements.



Coordinating and contributing to responses to
Agency queries and performing quality review of regulatory CMC submissions
• Deliver projects in either pharmaceutical / consumer products / Over the counter (OTC)
drug products as per client portfolio/requirements
• Ensure timely delivery of error-free, high-quality CMC documents that meet
international standards of written English and relevant technical requirements following
internal/client-specific style guides/templates
• Demonstrate expertise at planning CMC submissions, including appropriate knowledge
management tools
• Participate in meetings with Client on a regular basis to understand the client’s
requirement and proactively support the team in meeting or exceeding the targets in
terms of quality and quantity within the agreed timelines
• Demonstrate in-depth understanding of content requirements, including awareness and
understanding of CTD format a

📌 Regulatory Consultant (Chandigarh)
🏢 CONTINUUM India
📍 Chandigarh