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Manager Regulatory Affairs

4.00 to 5.00 Years   Mumbai City   01 Jun, 2020
Headstrong
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other SoftwareIT Operations / EDP / MIS
EmploymentTypeFull-time

Job Description

Manager - Regulatory AffairsWith a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us. Are you the one we are looking for We are inviting applications for the role of Manager, Regulatory affairs. The person will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Responsibilities:

  • Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
  • Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory results for assigned products across the product lifecycle
  • Identify and communicate potential regulatory issues to GRACS CMC, as needed
  • Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Capability to handle multiple priorities and balance work to achieve business goals.
  • Demonstrated effective leadership, communication, and interpersonal skills.
Qualifications we seek in you! Bachelors degree required in science, engineering or related field (advanced degree preferred).,

Keyskills :
handlemultiplepriorities environmentalimpactassessment qualityassurance regulatoryissues regulatoryaffairs analyticaltesting pharmaceuticalmanufacturing go visit color testing mc

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