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Urgent Hiring: Lead Consultant in Regulatory Affairs Publisher at Remote

Dear Partner,

Hope you are doing well!


Job Title: Lead Consultant in Regulatory Affairs Publisher

Location: Remote - Need candidates only from EST



Responsibilities

  • Provide support in Project management of dossier compilation, ensure transparent cross-functional planning and tracking of the compilation process.
  • Leads initial Submission Kick-off partnering with Strategist.
  • Owner of dynamic Submission Project Plan timelines capturing dependencies for each Module and Dispatch Date.
  • Coordinate content related Team/Management Reviews.
  • Establish, maintain, and adhere to Submission Project Plan timelines agreed upon as a team: Identify documents on the critical path.
  • Review of approved submission documents of Module 2 as per submission content plan.
  • Conduct and participate submission team meetings with GRS and maintain positive relationships with contributors/partners and oversee submission content plan from Module 2 to Module 5.
  • Communicate changes/critical updates during tracking team meetings to team members and Escalation of issues if timelines are at risk of being delayed.
  • Participate in Technical Quality Review for Modules 1-5 for final approval for utmost quality and sign off for on-time dispatch to Health Authorities
  • Frequent exchange and close collaboration and support with GRSs
  • Provide guidance to publishers while compiling content and publishing of submission dossier, preparing dispatch of dossiers, and submitting to Health authorities.


Regards,


Sayed Naqvi

VBeyond Corporation

IT Recruiter| US Operations

E: syedn@VBeyond.com | www.vbeyond.com

390 Amwell Road, Suite # 107, Hillsborough, NJ 08844

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