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Sr. Specialist, Regulatory Project Management

3.00 to 6.00 Years   Chennai   17 Mar, 2023
West Pharmaceutical Services
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    • Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers for submission to Health Authorities [DMFs, MAFs, 510(k)s] in compliance with regulations, guidelines and procedures.
    • Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.
    • Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.
    • Review technical project documentation such as protocols, summary reports, regulatory plans, certifications, correspondences, and external communications, as needed, providing guidance and direction where applicable.
    • Provide customers with West product related information and data as required for regulatory submissions to European and Rest of World agencies.
    • Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
    • Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.
    ,

Keyskills :
Sr Specialist

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