Job Opportunities API

Stellenbeschreibung Specialist, International Labeling Support The Opportunity • Exciting opportunity to join an innovative and trusted Global biopharmaceutical company • Permanent Full-time opportunity • Work autonomously whilst being supported, encouraged and being part of a trusted Global leading Pharmaceutical organization The Specialist, International Labeling Support (ILS) will partner cross functionally within Global Regulatory Affairs & Clinical Safety (GRACS) and cross divisionally where applicable to ensure Labeling and Artworks regulatory operational activities within scope of ILS are planned, managed, and executed timely, accurately and in a compliant way. The role is responsible for supporting local labeling implementation activities, maintaining regulatory records and databases, and driving operational excellence through continuous process improvement initiatives. What you will do: • Prepares high-quality labeling and artwork package aligned in accordance with company requirements and provides operational support to Country Regulatory Affairs (CRA) for regulatory activities (database maintenance, regulatory record management) within the ILS scope of work. • Ensure labeling and artwork deliverables are completed accurately and within established timelines. • Supports the preparation of the metrics for the designated business process. • Collaborates with Global Labeling, CRA, and other stakeholders to resolve labeling and artwork-related queries. • Supports necessary updates to process documentation, work instructions, and training materials. • Participate in cross-functional initiatives that identify opportunities to improve, simplify, and streamline processes and tools. What You Must have • Bachelor's degree (Pharmaceutical Sciences, Biotechnology, Life Sciences, Pharmacy, or a related discipline is preferred) • Minimum 2 years of experience in the pharmaceutical, biotechnology, healthcare, or related industry. • Prior experience in Regulatory Affairs, labeling and artwork management, CMC, quality, compliance, or regulatory operations is preferred. Experience with regulatory systems, databases, or document management systems is an advantage. • Strong organizational skills with the ability to manage multiple priorities and meet deadlines. • Good interpersonal and communication skills, with the ability to collaborate effectively across functions and regions. • Detail-oriented with a strong focus on quality, accuracy, and compliance. • Proficient in Microsoft 365 applications • Open to exploring emerging technologies, including AI-enabled solutions, and applying them creatively and responsibly to enhance business processes and ways of working. Required Skills: Biologische Wissenschaften, Biotechnologie, Biowissenschaften, Detailorientiert, Einhaltung gesetzlicher Vorschriften in Zulassungsangelegenheiten, Geschäftsprozesse, Kontinuierliche Prozessverbesserung, Neue Technologien, Operational Excellence (OPEX), Pharmazeutische Wissenschaften, Pharmazeutische Zulassungsangelegenheiten, Prozessdokumentation Preferred Skills: Anreizvergütung, Bindung der Kunden, Empathie, FDA-Vorschriften, Globales Kraftmanagement, Kommunikation, Kreativität, Medical Affairs, Organisatorisches Verhalten, Regulatorische Compliance, Verkauf Current Employees apply HERE Current Contingent Workers apply HERE Personalberatungsvertreter, bitte sorgfältig lesen Merck & Co., Inc., Rahway, NJ, USA, auch als Merck Sharp & Dohme LLC, Rahway, NJ, USA, bekannt, akzeptiert keine unaufgeforderte Unterstützung von Personalvermittlungsfirmen. Alle Lebensläufe, die von Personalberatungen an einen Mitarbeiter unseres Unternehmens gesendet werden, ohne dass eine gültige schriftliche Vermittlungsvereinbarung für diese Position besteht, gelten als alleiniges Eigentum des Unternehmens.  Im Falle der Einstellung eines Bewerbers durch unser Unternehmen in Folge einer Agenturempfehlung wird keine Gebühr entrichtet, sofern keine entsprechende vorherige Vereinbarung besteht. Wenn Vereinbarungen mit der Agentur vorhanden sind, sind die Einführungen positionsspezifisch. Bitte keine Anrufe oder E-Mails. Mitarbeiter-Status: Fest angestellt Umzug: Visa-Sponsoring: Reiseanforderungen: Flexible Arbeitszeitvereinbarungen: Hybrid Schicht: Gültige Fahrerlaubnis: Gefahrstoff(e): Job Posting End Date: 08/28/2026 *A job posting is effective until 11:59:59PM on the day BEFORE  the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.