Success of Engineering Projects mostly relies on key individuals demonstrating Intrapreneurial Leadership, and the best way to develop these skills is through hands-on consulting roles—working alongside established intrapreneurs in international companies, contributing to managing stakeholders' engagement, workflows' reliability, or solutions' sustainability.
Perhaps you’ve seen what happens when regulatory strategies fail to anticipate market expectations or compliance pitfalls. As a seasoned specialist, you know how critical it is to avoid costly delays, rejected submissions, and regulatory interventions that can derail an entire product lifecycle.
We would therefore welcome you at AETHER to support Intrapreneurial Projects, as a senior Regulatory Affairs Consultant:
The scope, here, is leading complex regulatory projects with strategic impact on global product development and ensuring flawless compliance across diverse markets.
The Key responsibilities expected from our consultant might include:
Support projects through high-quality and detail-oriented execution, ensuring accuracy and meeting expectations:
- Define regulatory strategies for complex development, registration, and variation projects at European and global level.
- Advise clients on strategic regulatory matters across the full product lifecycle.
Support projects with rational and data-driven assessments of costs, quality, and timelines, providing objective analyses for decision-making:
- Oversee preparation and submission of regulatory dossiers (CTD, eCTD) to authorities such as EMA, FDA, MHRA, and PMDA.
- Evaluate the impact of evolving regulations (EU MDR/IVDR, FDA, ICH) and implement action plans.
- Support audits and regulatory inspections, ensuring compliance in all activities.
- Identify new business opportunities and help prepare technical and commercial proposals.
Support projects by facilitating communication and reporting between stakeholders:
- Act as primary contact with health authorities, take part in scientific advice meetings, and manage complex queries.
- Mentor and provide technical guidance to regulatory teams and junior consultants.
The experience we are actively looking for:
- Master’s degree or PhD in Life Sciences (Pharmacy, Biology, Chemistry, or equivalent).
- Minimum of 8 years’ experience in Regulatory Affairs within pharmaceutical, biotech, or medtech industries.
- Proven expertise in EU regulatory frameworks (EMA, MDR/IVDR) and knowledge of FDA and/or other global regulations.
- Track record of managing complex regulatory projects and leading cross-functional teams.
- Excellent communication and negotiation skills in Dutch and English; French is an asset.
- Valid work and residence permits for Belgium (mandatory for non-EU candidates).
- Immediate availability and presence in Belgium are preferred.
Your best career choice will be one that propels you toward becoming a future intrapreneur or entrepreneur in your field of expertise.
Check with AETHER if more impactful opportunities are relevant for you. For the sake of Business reactivity, priority is being given to candidates who are already living in Belgium and are available rapidly.
