| Hi There,
Hope this email finds you well.
My name is Ira and I'm Executive Technical Recruiter at Vbeyond Corporation, a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is the summary of the position.
Responsibilities Regulatory Submission Management: - 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.
Qualifications we seek in you! Submission Publishing: - 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 RIM; 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.
Requirements: - In depth working knowledge of industry standard publishing systems and desktop applications.
- Expertise with Publisher applications
- Effective communication, time management and organizational skills.
- Technical Trouble shooting
- Flexibility to adapt to a changing environment,
- Demonstrated project management and leadership skills.
- Skilled at fostering customer relationships and driving collaboration.
- Understanding of global regulatory processes and requirements.
- Strong attention to detail, ability to multi-task.
- Expertise with industry standard electronic document management system
- Relevant years in Publishing and/or related Regulatory/Pharmaceutical area
Qualifications Pharmacy/Science Preferred Qualifications / Skills - Enthusiasm & confidence
- Adhere to our principles and values.
- Time Management skills.
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