Regulatory Operations Manager

2 days ago

Hyderabad Secunderabad Telangana, India beBeeCompliance Full time ₹ 1,04,000 - ₹ 1,30,878

Regulatory Operations Manager

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  • The ideal candidate will oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions.
  • A thorough understanding of regulatory reviews is essential to ensure alignment with country-specific requirements and ICH guidelines.
  • The successful candidate will coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions.
  • Effective management of regulatory responses to queries and deficiency letters from health authorities and clients is crucial to ensure resolution within timelines.
  • The ability to assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation is vital.
  • Leadership in lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions is necessary.
  • The role involves preparing regulatory documents for GMP inspections, tender submissions, and related regulatory filings.
  • Staying updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations, is key.
  • Providing regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements is a critical aspect of the job.
  • Maintaining and updating regulatory trackers, databases, and dashboards to monitor project status and deadlines is essential.
  • Supporting the development of regulatory strategies for new product launches and geographic expansion within Asia is also required.
  • Ensuring compliance with global and local regulatory SOPs and documentation standards is paramount.

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