Executive Mrc
Job Description
Major accountabilities:
• Life cycle management of Marketing Authorizations (MAs). Core experience in new submissions and life cycle management in major markets EU/US/CAN/JP/AUS/BR/CN will be an added advantage.
• New submissions in Most of World (MoW) regions and its planning as per targets
• Responsible for MA transfers and maintaining product history as per defined timelines and processes.
• Author high-quality CMC documentation (dossiers) for health authority submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
• Organize high-quality CMC documentation (dossiers) for health authority submission, from license partners, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
• Experience of work-sharing and super grouping variations submissions.
• Prepare CMC responses to health authority questions during development, registration, and product lifecycle.
• Regulatory evaluation of change controls and various other quality events (e.g. Deviations, OOS/OOT/OOE etc.) for possible regulatory impact. Experience on managing administrative changes will be an added advantage.
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Job Detail
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Job IdJD3391483
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IndustryNot mentioned
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Total Positions1
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Job Type:Contract
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationIN, India
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EducationNot mentioned
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ExperienceYear