Regulatory Consultant - CMC

Position: Regulatory Senior Consultant/ Consultant - CMC
Location: Hybrid (80 % remote, 20 % In office)

OFFICE: CHANDIGARH
Reports To: Manager or above, Regulatory Affairs
Company Overview
Client 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 Job Description Confidential

• 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 escalate 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

Education

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

Work Experience

Minimum 6-10 years of regulatory affairs/operations experience in the relevant area (e.g. Pharma, Consumer, Medical device)