Key Responsibilities
- 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 to be 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.
- Submission Publishing and performing final technical quality review and technical validation (eCTD) for Canada and US submissions.
- Should have knowledge about NDS, ANDS, IND, DMF, NDA and BLA submissions. e.g. Safety Submissions, Annual reports, OPDP submissions, Protocol and amendment, Original application.
- Notifying relevant stakeholders that the Submission is ready for approval.
- Dispatching submission to HC and US FDA through ESG Gateway.
- Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIMS communicating submission receipt to key stakeholders.
- Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence.
Qualifications
- A minimum of bachelor’s degree in pharmaceuticals or closely related field.
- Ability to learn and adopt to changing trends in pharma and medical sciences space.
- Good communication and interpersonal skills.
- Willing to work and collaborate with other teams.
What We Offer
🌍 Flexible remote/hybrid work environment.
💰 Competitive salary with performance bonuses.
📚 Learning and certification opportunities.
🎉 A dynamic and collaborative work culture.
How To Apply
Interested? Submit your resume here or send your resume to hr@vysoftinc.com with the subject: Regulatory Affairs Specialist Application – [Your Name]