You should have relevant years of experience in Publishing - regulatory affairs.
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 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.
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
5+ years in Publishing and/or related Regulatory/Pharmaceutical area
Qualifications
Pharmacy/Science
Preferred Qualifications / Skills
Key Attributes
Enthusiasm & confidence
Adhere to our principles and values.
Time Management skills.
Comments For Suppliers
Capped at 900 hours over 6 months. If the contractor leaves before the contract end date, then the hours will be averaged to 150/month and any hours exceeding this average will be adjusted in the last month and payment made accordingly
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
IT Services and IT Consulting
Referrals increase your chances of interviewing at QuantumBricks by 2x