Regulatory Coordinator

4 days ago

Delhi, Delhi, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 13,00,000

Job Title:

">Regulatory Coordinator">

Job Description:

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  • The Regulatory Coordinator will be responsible for ensuring timely approvals from FDA Loan License units by seamlessly coordinating with internal stakeholders and FDA teams for submission of various applications.">
  • The person in this role will develop good relationships with concerned external stakeholders and undertake advocacy to support licensing approvals for Cipla LL products.">
  • Key accountabilities include timely regulatory approvals from State FDA and CDSCO offices for loan license units, as well as developing strategies and coordinating with internal stakeholders to ensure timely applications and resolution of queries and approvals.">
  • The Regulatory Coordinator will also be responsible for building relationships with external stakeholders, including FDA and CDSCO officials, and maintaining regular engagement rhythms with these stakeholders.">
  • Additionally, the person in this role will check, monitor, and track timely releases of CMCL for local and export markets, as well as approve packaging labels as per new regulatory notifications and circulars.">
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Required Skills and Qualifications:

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  • Good coordination and communication skills are required for this role.">
  • The ideal candidate should have experience with FDA and CDSCO online applications and be well-versed in regulatory requirements and pharmacopeial changes.">
  • A degree in B.Sc or B.Pharm is preferred, along with 5-10 years of relevant work experience in the pharmaceutical industry.">
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Benefits:

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  • This role offers opportunities for career growth and development in a dynamic and fast-paced environment.">
  • The successful candidate will have the chance to work with a talented team of professionals and contribute to the success of the organization.">
  • Professional development opportunities, including training and mentorship programs, will be available to support the growth and advancement of the Regulatory Coordinator.">
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Dimensions:

">
  • ">
  • Timely approvals for loan license locations are critical to the success of this role.">
  • The Regulatory Coordinator will be responsible for making key decisions related to various FDA and CDSCO applications and submissions at state FDA and CDSCO offices.">
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Keyword:

">Regulatory",

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