Regulatory Affairs Specialist
Within the Quality team, you are the specialist responsible for Regulatory Affairs. The team shares a passion for getting things right the first time and operates with a strong customer focus. You are fully aware that customers depend on the accuracy, safety, and effectiveness of products and services that improve lives worldwide. Additionally, within the quality environment of the site, there are opportunities to further explore and collaborate on regulatory compliance activities that involve interactions with local and foreign health authorities.
Your responsibilities will include:
Regulatory Knowledge and Expertise:
- Stay abreast of procedural and CMC-related regulations, monitoring pharmaceutical regulations and participating in specialized industry working groups.
- Promote and capture regulatory services as part of our integrated offering, partnering with the business to define strategies.
- Author and review CMC/CTD M3-Quality documents for clinical and commercial applications across various markets.
- Maintain customer product registration information and translate it into production and quality control master documents.
- Participate in Change Control processes by defining regulatory requirements and ensuring compliance with evolving regulations.
- Drive adherence to key deliverables' plans, contributing to Global Regulatory Affairs reporting with a focus on regulatory services metrics.
To be successful in the role of Regulatory Affairs Specialist, you should demonstrate good adaptability to a dynamic work environment, agility in interactions with stakeholders, and a customer-centric attitude coupled with business acumen
Furthermore you bring:
- At least a Bachelor's degree in Life Sciences (Pharmacy, Chemistry, Microbiology).
- Several years of demonstrated experience in a CMC regulatory role within the biopharmaceutical industry.
- Proficiency in biologics CMC regulatory requirements for clinical and commercial applications according to EMA, FDA, ICH would be a good asset.
- English language spoken and written is a must
Questions or interested?
Senior Recruitment Specialist
+31 6 1238 7775