Job Description

Consultant - CMC (North America), Regulatory Affairs Location: WFH Budget : 9 LPA Work Experience : 3-5 year Must have : CMC, M-3 experience in North America 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 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 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

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