Regulatory Consultant CMC (Global)

PERSOL; Chandigarh; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

PERSOL is seeking a Regulatory Consultant CMC (Global) to work on regulatory filing projects for EMAE and APAC markets. The role is hybrid with partial remote work and office presence in India.

You will author and coordinate CMC activities for registrations, post-approval changes, renewals, and line extensions, ensuring high-quality, compliant submissions and timely delivery across global clients.

Qualifications

• Minimum 6 years of regulatory affairs/operations experience in the relevant area (e.g. Pharma, Consumer, Medical device).
• Experience with global regulatory submissions (US/EU/APAC) and CTD formats.
• Strong written and spoken English with meticulous attention to detail.
• Ability to work under minimal supervision and meet deadlines.

Responsibilities

• Collaborate with global clients on regulatory filing projects for EMA/APAC markets. The key delivery areas include Pre and Post approval CMC authoring, preparation, and submission.
• Independently author and coordinate CMC activities for new registrations, post-approval changes, renewals, annual reports, and line extensions; respond to agency queries and perform quality review of submissions.
• Deliver projects for pharmaceutical, consumer products, or OTC drug products per client portfolio; ensure timely, high-quality CMC documents that meet international standards.

Education

M.Pharm/PhD or equivalent in Regulatory affairs

Tools

MS Word

Adobe Acrobat

Documentum

Job description

Position: Regulatory Consultant CMC (Global)

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

Reports To: Manager or above, Regulatory Affairs

Functional Responsibilities

• Work with global clients on regulatory filing projects for EMAE and APAC markets . 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 clients 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 appropriately 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.

• North America experience in ANDA, NDA, IND, and basic CMC Life Cycle Management supplements, as well as Canadian filings.
• EU experience in initial filing and life cycle management (Type 1A, Type 1A/1N, Type 1B and Type II variations).
• 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

M.Pharm/PhD or equivalent higher degree in a relevant discipline (preferably Regulatory affairs, Pharmaceutics, QA, Industrial Pharmacy, Life Sciences)

Work Experience

• Minimum 6 years of regulatory affairs/operations experience in the relevant area (e.g. Pharma, Consumer, Medical device)

Mail - [e-mail]