Regulatory Affairs Publisher

Company: Cyberthink, Inc
Location: Avenel
Posted on: May 23, 2023

Job Description:

Job Title: Regulatory Affairs Publisher

Location: Avenel, NJ

Job Description:

Inviting applications for the role of Lead Consultant in Regulatory Affairs Publisher 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.

cyberThink is an Equal Opportunity Employer

Anupam Amita Team Lead cyberThink (

Leader in Staffing and IT Services since 1996

Keywords: Cyberthink, Inc, Elizabeth , Regulatory Affairs Publisher, Other , Avenel, New Jersey