We are currently recruiting a Regulatory Affairs Director for an international pharmaceutical and medical device company. The role is available due to the companies ambitious growth plans and expansion across Europe and US. The company has a number of products within skin/wound care and also a number of products in the pipeline.
As Regulatory Affairs Director you will be responsible for planning regulatory affairs activities and ensuring all products are in compliance with regulations and standard operating procedures (SOP's). You will be responsible for existing countries where the focus is medical devices and new countries where focus is FDA and biologics.
- You will be responsible for product registration submissions, such as, FDA submissions, EU notified body submissions and other regulatory documents
- Advise in market access strategies and have full responsibility of compliance with the ethical codes of conduct and of transparency guidelines related company products.
- Develop and implement regulatory strategies that ensure that products, procedures and policies meet applicable regulations in the countries where the company operates
- Serve as an internal resource to address and resolve any questions or issues of a regulatory nature.
- Investigation of vigilance cases and reporting to the relevant authorities according to applicable legislation and company SOPs
- Can act as Person Responsible for Regulatory Compliance or as back-up
Profile and Qualifications
- You will have a degree in medicine/pharmacy or other healthcare related university degree
- You will have 6 years plus experience of working within the regulatory affairs field in a pharmaceutical environment
- You will have an in depth knowledge of applicable laws and standards such as GMP, GDP, EU, MDR, c-GMP etc
- You will possess excellent communication skills with both team members and external authorities
- You will have excellent planning and organisational skills
- Excellent English (professional) Dutch, French or German would also be an asset.
This is an excellent opportunity to join a leading company who offer an innovative and inspiring work environment and career growth.