Regulatory Affairs Consultant
il y a 1 semaine
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
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