Expert Regulatory Strategist

3 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 21,12,000 - ₹ 28,38,800
Regulatory Affairs Manager Job Description

The Regulatory Affairs Manager plays a crucial role in ensuring the successful execution and implementation of global regulatory activities for commercial products.

This position is responsible for communicating the regulatory strategy, risks, and issues to senior management within the department. The Regulatory Affairs Manager coordinates communication, collaboration, and coordination with site and regional representatives to develop and execute global regulatory activities.

The ideal candidate will contribute to product teams and act as product lead or principal for one or more products. They will provide strategic regulatory input and risk assessments for product teams; execute regulatory strategy with respect to preparation of submissions; comply with critical processes; identify need for process changes to meet internal initiatives and changes in external policy and guidance; report needs for process changes; and contribute to process improvements.

Key Responsibilities:

  • Generate and execute global and country-specific regulatory strategies.
  • Provide CMC regulatory strategy for assigned projects by defining minimal filing requirements, submission strategy, and regulatory risk assessments.
  • Develop global dossiers for CMC content for initial submissions, variations, and amendments.
  • Support change management activities.
  • Develop response strategy and respond to health authority questions.
  • Liaise with other functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution, and supply plans.
  • Liaise with local regulatory teams to align on filing strategy.
  • Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current.

Qualifications:

The ideal candidate will have a strong background in regulatory affairs, with experience in manufacture, testing (QC/QA or clinical), or distribution. A Doctorate degree or Master's degree with 3 years of directly related experience is preferred. Experience in regulatory CMC activities is also highly valued.

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