Regulatory Affairs Professional - Submission Lead
- Employer
- Parexel
- Location
- Warszawa, Poland
- Salary
- Competitive
- Start date
- 26 May 2023
- Closing date
- 22 Jun 2023
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- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
As a Regulatory Affairs Submission Lead you will work closely with the Global Regulatory Lead/ Regional Rep/EU Agent, Functional teams and Local Operating Company regulatory contacts to confirm requirements, deliverables and agree timelines and plan/implement delivery strategy for Initial MAA/NDA submission. You will ensure that dossiers are prepared in compliance with Regulatory Authority regulations and guidelines and in line with SOPs and working practices. You will also plan and ensure delivery of life cycle activities for products registered in EU (for example variations, periodic benefit risk evaluation reports (PBRER), paediatric investigation plan) and appropriate content for a range of submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with internal processes and policy as they apply to the role.
Key Responsibilities:
- Primary contact for Global Regulatory Lead/ Regional Rep (TG) for delivery of submissions or strategy components for assigned products; planning own and submission team activities to ensure delivery to agreed timeframes and appropriate content
- Responsible for the development and implementation of the submission strategy for new files, line extensions & new indications in non-major markets Ensures quality of both own and submission teamwork and compliance with regulatory guidelines and process as they apply to the role.
- Responsible for the implementation of the submission strategy for New Files in major markets
- Accountable to GRL/ Regional Rep (EU Agent)/ C&EP lead for delivery of MAA and Lifecycle maintenance Submissions for an assigned product in development or marketed product for European Market.
- Through collaboration with contributing functional lines within and outside of GRA, including LOC, creates and maintains a detailed Submission Plan that captures, key activities and timelines associated with delivery of that content and credible dispatch dates
- Participates and/or leads submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process.
- Possess in depth knowledge of our processes, ways of working and current EU and ROW market guidelines and provides support to submission coordinator in resolving issues and bottlenecks to ensure a smooth execution of submission strategy
- Monitoring and tracking if the submissions are on schedule and as per plan.
- Works with staff from other functions and should be able to work with senior leaders in development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues.
- Undertakes Regulatory Matrix Team (RMT) secretariat role.
- May be responsible for leadership of relevant submission team or other maintenance activities associated with an approved EU product, including product renewals, label harmonization, PBRER submissions etc
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
Skills and Experience required for the role:
- University degree in a life science discipline, or equivalent
- 3-5 years of Global/EU/ROW Regulatory submission experience - Knowledge of regulatory agency guidelines
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Excellent project management, leadership & organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines and managing multiple submissions simultaneously
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
- Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
- Fluent in English and the local language
Company
When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.
How to describe Parexel’s culture in one word:
Working With Heart™ - Christina's perspective:
Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
United Kingdom
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