Support in Regulatory Affairs – Regional RA Liaison

Support the success of global regulatory submissions by keeping processes seamless, structured, and on track.

R&D Partners is seeking a Support in Reg. Affairs – Regional RA Liaison to join a leading biotechnology company. This position provides key procedural, administrative, and planning support to enable regulatory submissions across multiple territories. The ideal candidate will have a strong understanding of the pharmaceutical lifecycle and regulatory processes, with the ability to manage multiple tasks effectively.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Provide administrative regulatory support during filing and review of new submissions and variations to ensure compliance with EU requirements.
• Plan and coordinate new submissions, variations, CHMP referrals, and FUM to meet submission deadlines.
• Draft Module 1 components and organize the collection of required documents.
• Collaborate with Regulatory Operations to establish submission timelines and Module 1 content.
• Work closely with Country RA Registration Managers to ensure timely submissions.
• Oversee and coordinate translation processes for centralized procedures to meet EMA deadlines.
• Maintain and update regulatory databases.
• Stay informed about EU procedural requirements and legislation.
• Participate as a Subject Matter Expert (SME) in relevant workstreams and projects as assigned by Regulatory Affairs Europe Senior Staff.

Key Skills and Requirements:

• Education: University degree or equivalent (e.g., A1 in Belgium), preferably in a science related to medicine.
• Experience: Minimum of 4 years in the pharmaceutical industry with knowledge of drug development and/or approval processes.

Skills:

• Strong organizational skills and ability to multitask.
• Excellent written and verbal communication skills in English.
• Ability to work across boundaries and act as an intermediary between teams.
• Attention to detail for reviewing regulatory documents and identifying potential errors.
• Familiarity with the end-to-end pharmaceutical lifecycle.
• Innovative mindset with the ability to evaluate and implement new ideas.
• Proven ability to coordinate tasks and meet deadlines.

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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