Regulatory Consultant / Senior Regulatory Consultant– CMC

CONTINUUM India LLP; Chandigarh; Hybrid; INR 1,200,000 - 2,500,000; Full time

Job summary

CONTINUUM India LLP is seeking a Regulatory Consultant–CMC with 6–10 years of regulatory affairs experience. You will work on regulatory filing projects for USFDA, EMA, MHRA and APAC, focusing on Pre and Post approval CMC documentation and submissions.

The role requires writing and coordinating CMC modules, ensuring timely delivery of high-quality documents, and collaborating with clients and internal teams across global markets.

Qualifications

• Minimum 6–10 years of regulatory affairs experience in Pharma/Consumer Care/Medical Device.
• Experience with USFDA, EMA, MHRA, APAC regulatory practices and CTD formats.
• Strong client communication and cross-functional coordination skills.
• Proficient in preparing and reviewing CMC documentation and submissions.

Responsibilities

• Work with global clients on regulatory filing projects for USFDA, EMA, MHRA, APAC, Canada etc.
• Scientific writing, review, and compilation of submission documents like module 2 and module 3 (CMC).
• Independently author and coordinate CMC activities for registrations, post-approval changes, renewals, and line extensions.
• Ensure timely delivery of high-quality CMC documents meeting international standards.
• Collaborate with stakeholders to understand client requirements and support timely delivery.

Skills

Regulatory knowledge

CMC submissions

Global regulation awareness

English communication

Education

MPharm/PhD or equivalent

Tools

Documentum

MS Word

Adobe Acrobat

Job description

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 new 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 and apply expertise to ensure global regulatory commitment tracking
• Prioritize and complete assigned workload appropriately under minimum supervision
• Proactively identify moderately complex issues and risks to project delivery in own work or work of the team and elevate accordingly with associated resolution proposals
• Work cross-functionally and in collaboration with key stakeholders/customers both internal and external
• Ensure that all training (internal training and client training) are successfully completed in a timely manner

Skills and general profile

• Good understanding of global regulations USFDA, EMA, MHRA, APAC, TGA, etc.
• Strong working knowledge of electronic document and submission standards
• Excellent communication skills and effective in a collaborative team environment
• Advanced skills in the use of MS Word, Adobe Acrobat, Documentum systems
• Effective interpersonal skills
• Strong verbal and written English skills
• Ability to work in a fast-paced, cohesive, collaborative team-oriented work Environment
• Commitment to highest quality outputs, including meticulous attention to detail
• Enthusiasm and pro-activity

Education

• MPharm/PhD or equivalent higher degree in a relevant discipline (preferably Regulatory affairs, Pharmaceutics, Industrial Pharmacy, Life Sciences)

Work Experience

• Minimum 6-10 years of regulatory affairs experience in the relevant area (e.g. Pharma, Consumer Care, Medical Device)