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Regulatory Regional Submission Coordinator Lead
Position Overview
The Regulatory Regional Submission Coordinator (Lead) is a key role responsible for coordinating all activities required to deliver regulatory submissions across assigned region.
Key Responsibilities
Regional Coordination & Stakeholder Management
- Coordinate the preparation, compilation, and submission of new drug applications and Lifecycle Manage (LCM) activities in alignment with submission strategy as defined by the Regional Regulatory Lead (RRL) and the submission team.
- Coordinate closely with the Global Submission Coordinators to ensure the completeness of the core documentation required to support regional submission planning and local requirements.
- The coordination of regulatory submission activities include notably:
- Organize the submission team meetings (“Kickoff Meeting”),
- Provide a draft of the Submission Content Plan (SCP) based on country-specific regulatory requirements and prior Health Authority observations to ensure continuous improvement.
- Facilitate effective communication among all stakeholders including CMC, labelling, RRL, Local Regulatory Responsible (LRR) or Regulatory Partner Representative (RPR),
- Open the required records in the submission planning tool and Regulatory Information Management System (e.g. Apollo and Veeva Registrations) and ensure that the records are duly completed and correct,
- Prepare the Submission Content Plan (SCP) based on country-specific regulatory requirements and prior Health Authority observations to ensure continuous improvement.
- Coordinate, request, and track documentation from the relevant SMEs to ensure timely and complete submission readiness.
- Update regularly the submission team on the status and timelines.
- Support the M1 documents preparation:
- Draft the M1 documents as required and coordinate their review with LRR or RPR,
- Provide operational support for labeling activities to RRL, LRR & RPR, preparation of annotated labeling for regulatory review, initiation and coordination of mockup requests in the Artwork Management System, tracking of print releases as required, and support to change control processes for local labeling updates. Ensure appropriate archiving of labeling documentation and that approved labeling is accurately and timely stored in DocNet.
- Upload M1 document to DocNet and fill in the SCP accordingly.
- Ensure the dispatch of the non-eCTD regulatory package to the LRR and RPR.
- Track the dispatched documentation for each country.
- Ensure that the submitted documentation is uploaded to DocNet for non-eCTD.
- Update Veeva as required, including uploading each question received by the HA in a record HAI.
- Ensure that all required aggregate safety reports have been requested on Veeva “Consolidated Safety Report List” and track their submission by creating the appropriate Veeva records (Regulatory Objective & Submission)
Project Management & Tracking
- Work collaboratively with Regions Leadership Team, the Parexel Project Lead (PL) and Parexel Workstream Lead (WSL) to monitor and track regulatory activities and deliverables.
- Ensure all regulatory efforts to align with agreed project metrics identified in the project governance structure.
- Maintain accurate documentation of submission timelines, milestones, and dependencies.
Risk Management & Escalation
- Proactively identify potential project issues, risks, and roadblocks that may impact submission timelines, quality, or regulatory approval.
- Escalate issues promptly to the Regions Leadership Team, Parexel Project Lead and Parexel Workstream Lead with appropriate context and proposed solutions.
- Monitor regional regulatory landscape changes that may impact submission strategies.
Quality & Compliance
- Support harmonization efforts across regions where applicable to optimize submission efficiency.
- Ensure adherence to SOPs, and regional requirements.
- Maintain awareness of regional regulatory updates and communicate relevant changes to the submission team.
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field.
- 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of regional regulatory submission processes.
- Experience with different international regulatory submission routes preferred (e.g. ACCESS, reliance pathways).
- Excellent project management and organizational skills.
- Strong communication and stakeholder management abilities.
- Proficiency in regulatory tracking systems and Microsoft Office Suite.
- Ability to work collaboratively across global and regional teams.
Key Competencies
Technical Competencies:
- Regulatory submission strategy and execution
- Project management methodologies
- Risk assessment and mitigation
Professional Competencies:
- Attention to Detail & Quality Focus
- Proactive Problem-Solving
- Builds and maintains strong relationships across diverse groups
- Articulates complex information clearly to varied audiences
- Manages multiple priorities and deadlines effectively
- Navigates diverse regional requirements and cultural contexts with sensitivity
Behavioral Competencies:
- Ability to work effectively in a matrix environment with multiple reporting lines
- Strong interpersonal skills and ability to influence without direct authority
- Adaptability and flexibility in a dynamic, changing environment
- Team collaboration and coordination across functional areas