Join a global leader in biotechnology and pharmaceuticals, dedicated to creating life-changing therapies. As a Regulatory Affairs Specialist, you'll be instrumental in ensuring the compliance and approval of innovative products worldwide. Collaborate with diverse teams to navigate regulatory landscapes, from development to post-marketing. Enjoy a dynamic work environment with a collaborative team, competitive compensation, and a robust pension plan. Learn about the growth opportunities available in this role.

Over het bedrijf

QTC Recruitment

Werving en selectie

Volledige vacaturetekst

Our client is a global innovator in the biotechnology and pharmaceutical sector, committed to developing breakthrough therapies that improve and extend lives. They are expanding their regulatory team and currently seeking a Regulatory Affairs Specialist to support the development and approval of life-changing products across global markets. If you're passionate about bringing safe and effective therapies to patients and thrive in a fast-paced, regulated environment, this is the opportunity for you.

This is how you will make the difference

As a Regulatory Affairs Specialist, you will play a key role in compiling, reviewing, and submitting regulatory documentation to health authorities such as the EMA and FDA. You’ll work cross-functionally with R&D, Quality, and Clinical teams to ensure compliance throughout the product lifecycle—from early development to post-marketing support. Your responsibilities will include preparing regulatory submissions (CTAs, INDs, MAAs, NDAs), responding to authority queries, maintaining product registrations, and monitoring regulatory changes that may impact the organization. You will also contribute to regulatory strategy development and support audits and inspections by ensuring that documentation is current, accurate, and audit-ready.

What you bring

You, as the ideal Regulatory Affairs Specialist, will recognize yourself in the following:

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field
3+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industry
Working knowledge of EU and US regulatory requirements (e.g., EMA, FDA, ICH guidelines)
Experience with regulatory submissions such as INDs, CTAs, NDAs, MAAs
Strong attention to detail and excellent communication skills in English (both written and verbal)

What's in it for you

What we offer:

We offer you the opportunity to join a company where your contributions will play a key role in shaping its future. You’ll work in a dynamic and stimulating environment, alongside a collaborative and supportive team. As the company continues to grow, you’ll benefit from ample opportunities for professional development. In return, you’ll receive a competitive compensation package, including a pension plan.

Gerelateerde zoekopdrachten

Compliance Manager Amsterdam Fulltime Amsterdam Vast contract Amsterdam Amsterdam Provincie Noord-Holland Compliance Manager Salaris Compliance Manager

Vacature opslaan

Gefeliciteerd, je bent succesvol ingeschreven!

Vanaf nu ontvang je automatisch de best passende vacatures automatisch in je mailbox.

Jouw inschrijving
Emailadres:
Functie:
Plaats:
Frequentie:

Wijzig je inschrijving

Ontvang als eerste nieuwe vacatures voor Compliance Manager in Amsterdam

Je e-mail

Frequentie

(Uitschrijven kan altijd via elke e-mail die je ontvangt)

(Uitschrijven kan altijd via iedere app die je ontvangt)