Sr. Specialist Regulatory Affairs Europe

Job Description

Senior Specialist Regulatory Affairs Europe

Do you want to be part of our Oncology team and help bringing new medical advancements to patients

We are an international network on the leading-edge of healthcare breakthroughs that help provide new reliable and compliant medical products practices and solutions to the world. We have a new exciting opportunity for an Associate Liaison Regulatory Affairs (Senior Specialist) to be based in Brussels (BE) Oss (NL) or London (UK).

As an Associate Liaison you will provide procedural administrative and planning support for new Oncology marketing authorization applications and variation submissions in the EU UK Switzerland and non-EU SEE countries under supervision from the (Senior) Principal Scientist of Regulatory Affairs. You will work on products approved through Centralized and Decentralized/MRP procedures collaborating with the (Senior) Principal Scientist and cross-functional teams.

Our department

Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). In GRACS we are always striving for operational excellence. We cover a wide range of activities related to getting products and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Our large portfolio in Oncology includes medicinal products at all stages of the marketing authorizations life cycle and span several therapeutic indications. Activities are numerous and the dedication and commitment of the team is very rewarding. Our portfolio provides the chance to learn something new every day!

What Youll Do

• Administrative support: Provides administrative support during filling and review of new product registrations and post-approval submissions (variations CHMP referrals Agency commitments etc.) in the EU and the UK Switzerland and non-EU SEE countries

• Coordinate submissions: Plan and coordinate regulatory submissions to ensure timely delivery.

• Prepare Module 1: Draft and organize regional administrative documents and liaise with internal teams for completeness and accuracy.

• Collaborate cross-functionally: Work closely with Regulatory Operations and Country RA Managers to establish submission timelines and align on submission strategy and execution.

• Manage translations: For centralized procedures oversee translation processes to meet EMA requirements.

• Artwork development: Coordinates new product artwork development and/or artwork updates implementation.

• Maintain compliance: Keep regulatory databases updated and ensure adherence to EU legislation and procedural requirements.

• Contribute to projects: Act as a subject matter expert in workstreams and process improvement initiatives.

What Were Looking For

• University degree in life sciences or related field.

• Several years of experience in the pharmaceutical industry with knowledge of drug development and approval processes.

• Strong organizational and project management abilities with the ability to manage multiple tasks and to prioritize them efficiently.

• Excellent written and verbal communication in English.

• Familiarity with EU regulatory procedures (CP DCP MRP) and Module 1 requirements.

• Ability to work in an international environment and coordinate multiple stakeholders.

• Detail-oriented with strong document review and QC skills.

• Proactive solution-oriented and eager to contribute to process improvements.

• Willingness to travel up to 5% for job-related activities.

Required Skills:

Preferred Skills:

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