[Hiring] Regulatory Affairs Specialist – Consultant @ClinChoice

Role Description

This role involves supporting regulatory affairs as a Sr. Product License Maintenance Manager (PLM) Compliance Support.

• Accountable for reviewing new certificate requests and forwarding to relevant suppliers for processing
• Responsible for NDA Annual Report compilation and Drug Listing submissions to FDA
• Manages multiple tasks simultaneously to ensure performance metrics and filing deadlines are achieved according to agreed targets and BOH due dates
• Liaise with necessary parties to collect information needed to submit the certificate request to the Contractor
• Track all rework through systems if rework is identified
• Forward request to the identified Contractor for processing within the timeframes identified by the relevant project team
• Manage legalization through Consular Services ensuring relevant administration and fees are completed and timelines adhered to
• Communicate with requestor, Contractor, or Consular Service to ensure request is processed, queries are answered, and timelines are met
• Project manage multiple requests simultaneously, ensuring filing deadlines are reached and next action dates are maintained in real time
• Escalate to Client and Contractor point of contact when timelines may not be reached
• Maintain Clients systems and process throughout processing of request to ensure real-time reflection of request is visible to all users
• Seek approval from Clients end lead for any certificates requiring fast tracking
• Support delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, and NDA Annual Report submission to FDA
• Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects
• Delivery of Product License Maintenance Portfolio in a timely and quality manner

Qualifications

• 3+ years Regulatory experience
• Experience submitting US Annual Reports
• Demonstrated ability to support international product approval
• Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines
• Proven technical aptitude and ability to quickly learn and apply new software, regulations, and quality standards
• Can demonstrate leadership and team skills
• Advanced Microsoft Office Suite skills
• Highly efficient communicator
• Acts decisively and seizes accountability
• Bachelor’s degree Level (desirable) or equivalent work experience
• Familiarity with pharmaceutical organizational structures

Requirements

• Key words: PLM, Regulatory Affairs, Product License