Product Regulatory Lead R&D
Walloon Brabant – contracting
#regulatory affairs #pharma #product life cycle #regulatory submission
You have experience in regulatory affairs in the pharma sector? You have an eye for details and for work well done? Keep reading your future job description.
Our partner is looking for a Product Regulatory Lead R&D to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
As Product Regulatory Lead R&D, you will Reporting to the VP R&D, the Product Regulatory Lead R&D is in charge of writing technical documentation to support Clinical Study Approvals, CE marking and FDA submissions and registrations. She/He ensures compliance of product technical documentation with regulatory and industry standards and ensures that Regulatory Standards are met as part of the Product Development Process.CMC variation management with external partner & internal partners
- Own technical/non-clinical product-related documentation according to Design Verification and Validation plan
- Write technical documents including Investigator Brochures, Product Risk Analysis, Verification & Validation Reports, and others as required
- Coordinate cross-departmental activities needed for successful technical document creation and submission
- Prepare technical documentation to support Clinical Study Approvals, CE-Mark applications, FDA regulatory submissions, and product registrations
- Work closely with Quality Assurance, Quality Engineering, and Quality Control in manufacturing to support validation strategies (processes and test methods)
- Maintain technical documentation to ensure compliance with internal QMS, regulations, and standards
- Prepare and present technical documentation in audits (internal and external, i.e. by Notified Bodies).
- Manage Product Lifecycle Management activities, re-submissions and amendments
- Support product registration processes
Who are you?
- Master’s degree, preferably Ph.D. degree in Science, Engineering or similar
- Strong technical writing skills in English (Investigator Brochures, Risk Management Reports, Technical Reports)
- Previous experience (5+ years) supporting or in Regulatory Affairs for Medical Devices Class, preferably IIb or III,
- Experience with and knowledge of applicable standards and regulation, such as ISO13485, Medical Device Regulations (MDR), FDA guidance documents, etc.
- Experience with Design Controls
- Fluent in English, written and spoken. Knowledge of another language is beneficial
- Good knowledge of Microsoft Office applications
- Excellent presentation skills
What can you expect?
Experis offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Patrick Mutamba Ilunga, [email protected] or 0497/05.50.92
