Your Role in Driving Innovation
Are you the kind of person who lives and breathes compliance, loves diving into the nitty-gritty of regulatory guidelines, and gets a thrill out of securing global approvals? Then we've got the perfect opportunity for you.
How You’ll Make an Impact
* Prepare and submit regulatory dossiers, in compliance to all regulatory requirements and guidelines.
* Implement regulatory strategies to secure timely approvals.
* Preparing and reviewing documentation
* Accountable for timely submissions and approvals.
* Manage communications with regulatory health authorities regarding submissions delivery and formatting.
* Answering questions from local health authorities regarding registered products.
* Maintain accurate and comprehensive regulatory documentation and records.
* Supports timely preparation of regulatory fees and performs the related administrative activities.
What You Need to Bring to the Table
* Bachelor or Master’s degree in pharmaceutical sciences, biomedical engineering, life sciences or related.
* A first experience in a regulatory role within the biotech or pharmaceutical industry.
* Proficient in regulatory dossier submissions
* Detail detective: your eagle eyes catch the tiniest regulatory nuances, and your documentation skills are the stuff of legends.
* Independent worker with strong team collaboration skills.
* You're always on the lookout for regulatory updates, ready to guide the team through any necessary transitions.
* Capable of managing multiple projects and prioritizing tasks effectively.
* Excellent cross-functional communication skills to engage with internal teams and external stakeholders.
* Proficient in English and Dutch, both written and verbal; additional languages are a plus.
Take your career to the next level - join us now!