CMC Post-Approval Specialist

2 weeks ago

Gurgaon, Haryana, India inVentiv Health Clinical SRE, LLC Full time
Responsibilities
">This role provides regulatory and technical support for assigned CMC post-approval variations, renewals, annual reports, legal entity name changes (LENC) and other lifecycle maintenance activities. Key responsibilities include:

  • Developing and reviewing module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, ensuring compliance with current government regulations and guidelines.
  • Assessing the change control issued by the quality or regulatory department, evaluating the regulatory impact of the change and developing a submission strategy.
  • Conducting research of existing product data relative to global or regional regulatory requirements to prepare gap analyses, product development plans, and other regulatory submissions.
  • Contributing to or preparing administrative and technical components of regulatory agency submissions for the IND, pre-approval submission packages, product registration applications, and post-approval maintenance.
  • Preparing briefing packages for regulatory agency meetings or scientific advice and contributing to or supporting agency interactions.
  • Managing and operationalizing the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines, scope of contract, budgets, and strategies.
  • Participating as regulatory support on multidisciplinary project teams, collaborating with clinical and technical experts to develop products throughout their life cycle.
  • Acting as a subject matter expert and helping team members with day-to-day trouble shooting activities, presenting solutions to project-related problems.
  • Preparing estimates for conducting regulatory services as part of single or multiple service proposals.
  • Supporting meetings with clients to discuss proposals, the status of ongoing projects, and general business development activities.
  • Ensuring compliance with appropriate global regulatory requirements and company policies and processes.
  • Preparing training materials and sharing best practices in the regulatory area, both internally and externally.
  • Participating as regulatory support in internal or external project audits.
  • Participating as regulatory support on internal cross-functional initiatives.
  • Contributing to the creation and/or maintenance of SOPs and other process-related documentation as required.
  • Providing support in oversight to team members in the execution of their project responsibilities.
  • Capable of identifying when to ensure line support required to provide additional guidance and direction.
  • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

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