Regulatory Affairs CMC – Great development opportunity!

Location:

Den Bosch – Noord-Brabant, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

131639561

Posted On:

04 March 2025

Regulatory Affairs CMC Consultant – Den Bosch Area, Netherlands

Are you a Regulatory Affairs professional with expertise in CMC (Chemistry, Manufacturing & Controls)? Do you enjoy analyzing regulatory gaps, defining global CMC strategies, and supporting customers in their interactions with health authorities? If so, this opportunity in the Den Bosch area could be the perfect next step for you!

Your Role

As a Regulatory Affairs CMC Consultant, you will play a key role in guiding customers through regulatory challenges in the pharmaceutical industry. You will support clients by assessing regulatory gaps, defining strategies, and preparing high-quality documentation for global submissions.

Your Key Responsibilities

* Conduct gap analyses & due diligence for customer projects.
* Analyze, interpret, and translate gaps into actionable CMC data generation strategies.
* Develop global CMC regulatory strategies, identifying opportunities for interactions with health authorities.
* Provide technical writing for clinical trial applications (e.g., IND eCTD modules 2.3 and 3, QIMPD-EU) for Phase I to pivotal clinical trials, as well as for marketing authorization applications (BLA/MAA) and post-approval variations.
* Prepare CMC-related regulatory documentation (e.g., ODD, PIP, Briefing Books, labeling, PRIME, and RMAT applications).
* Support customers with submissions and responding to health authority requests for information.

What We Offer

* A flexible working environment with the option to work remotely.
* A dynamic and innovative work setting with exciting challenges.
* The opportunity to collaborate with global pharmaceutical companies and health authorities.
* A competitive salary and strong benefits package.

If you have a strong background in Regulatory Affairs CMC and are looking for a new challenge in the Den Bosch area, we would love to hear from you!

x1F4E9; Apply now or reach out for more details!

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