Regulatory Affairs Specialist

Regulatory Affairs Specialist (f/m/d) At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations. Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for. Department Info The Regulatory Affairs team, mainly operating from Leuven (Belgium), is part of the larger Quality, Regulatory Affairs and Vigilance department. The team provides support in regulatory dossiers and post market surveillance to internal and external Terumo customers in the EMEA region. We are now looking for a Regulatory Affairs Specialist, to support the business in our newly acquired entity in Leverkusen, Germany. Job Summary As Regulatory Affairs Specialist in our CDMO-like organization in Leverkusen, you will play a key role in ensuring effective communication and collaboration with regulatory authorities, maintaining MIA and GMP compliance. Your role will focus on interpreting and implementing international regulatory requirements, managing regulatory activities for clients, and maintaining accurate records of submissions and communications. While you develop and support regulatory strategies, you collaborate cross-functionally with our Commercial, Marketing, Quality Assurance, and Legal teams to ensure compliance aligns with business objectives. Job Responsibilities Lead and actively participate in meetings with regulatory authorities (EMA, FDA and local authorities) to clarify regulatory positions and ensure alignment with global expectations Monitor, interpret and assess international regulations, guidelines, and standards relevant for the business, evaluating their impact on the Quality Management System (QMS), manufacturing sites, production processes and regulatory strategies Maintain audit-ready regulatory and CMC documentation, including submissions, correspondence, variations and amendments Evaluate site or process changes for regulatory impact and provide clients with required CMC data and certificates (CoA, GMP, MIA, DMF) Manage regulatory activities across product registration, lifecycle management, and ongoing compliance, ensuring labelling accuracy and supplier adherence Support inspections and audits by maintaining accurate records and responding promptly to CMC-related regulatory queries Develop and implement regulatory strategies that enable timely approvals, effective post‑approval changes, and alignment with commercial and client objectives Act as a regulatory liaison, providing proactive guidance and ensuring cross‑functional alignment across departments and stakeholders Communicate regulatory updates, risks and compliance requirements to support informed decision‑making and successful project delivery Profile Description University degree in Life Sciences (e.g. Chemistry, Biology, Pharmacy, Chemical Engineering, ...) or a closely related pharmaceutical discipline 1‑3 years of professional experience in the pharmaceutical industry, ideally within R&D, Regulatory CMC or a closely related area Solid understanding of GMP principles and regulatory requirements for CMC documentation Experience liaising with regulatory authorities and clients is a distinct advantage Excellent communication skills, with a proven ability to work effectively in a cross‑functional environment Comfortable operating in both German and English, with outstanding communication ability in both Offer Rewards that match your dedication: We offer a competitive salary and benefits package that sets the benchmark for rewarding your commitment. Join a passionate team: Become a valued member of our passionate and high‑performing team where everyone is treated with respect. We are dedicated to creating a diverse, equal, and inclusive work environment. Invest in your development: At Terumo, we invest in our associates by providing a wide range of development opportunities to help you grow both personally and professionally. Work‑life flexibility: Experience a hybrid way of working that balances office and home‑based work to the fullest. Connect with us: During the recruitment process, you'll have the opportunity to engage in meaningful conversations with the hiring manager and other enthusiastic Terumo associates. Contact Person Marjolein Buyl Talent Acquisition Business Partner Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.