Lead Associate Regulatory Affairs
Job Description
With 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.
Inviting applications for the role of Lead Associate, Regulatory Affairs
Will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies along with the preparation and review of the information required for the development of regulatory CMC dossiers for commercial products.
Responsibilities
- Identify the regulatory submission requirements, based on regulatory guidelines.
- Liaise with local country regulatory teams to verify the submission requirements
- Plan the due dates, and coordinate the on-time delivery of the renewal content, to meet regulatory requirements
- Review the submission content for accuracy and completion against the submission requirements
- Coordinate team review, electronic content publishing, and release of the submission content
- Ensure all required submission content is obtained
- Support response to health authority questions or local subsidiary requests for additional information to support the submission
Minimum Qualifications
- Bachelor's degree required in science, engineering or related field
- Advanced degree preferred
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Job Detail
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Job IdJD2945783
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear