Fraction IT Solutions Pvt. Ltd.
Location
Aurangabad | India
Job description
Experience: 10 years to 15 years
Location: Aurangabad
Client: Pharma client(API)
Fraction IT Solutions Pvt Ltd is hiring Regulatory Affairs (DMF) experts for its Pharma client which is an established Capability Development center at Aurangabad.
Registration and Regulatory strategy
1. Reviewing and assessing proposals to regulatory pathways for all NCEs, NDAs, ANDAs, USDMF, CEP, EU ASMF & for new DMFs for all markets.
2. Providing strategic input and technical guidance on regulatory requirements for all NCEs, NDAs, ANDAs, USDMF, CEP,EU ASMF & for new DMFs for all markets to development teams.
3. Assesses all requirements and potential obstacles for submission and develops solutions to address anticipated deficiencies
4. Review all NCEs, NDAs, ANDAs, USDMF, CEF, EU ASMF & for new DMFs for all markets & all regulatory submissions
5. Supervising regulatory operations functions to create and maintain regulatory information systems that meet organization objectives
6. Developing and managing programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
7. Participating in pre approval inspections to provide knowledge & critical analysis
Post approval life cycle ManagementÂ
1. Evaluating proposed manufacturing changes to USDMF, CEP, EU ASMF & DMFs for all markets and proposed plans for changes that do not require submissions.
2. Reviewing and approving change controls to determine the level of change and consequent submission requirements, assesses potential impact on business objectives, and communicates that impact accordingly with customers.
3. Implementation of systems to track required reports, Amendments/ supplemental submissions and other post marketing commitments.
4. Reviewing and approving required reports, supplemental submissions and other post marketing commitments.
Business Domain
1. Performing regulatory due diligence and identifying risks for executive managementÂ
2. Assessing and approving work plans to ensure appropriate staging of activities and with clearly defined milestones.
3. Evaluating corporate policies to mitigate regulatory risk to ensure adequate compliance to help the company achieve its business goals.
Job tags
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