About this role
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics.
Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
Your Role
Ensure technical submission readiness of submission-relevant documents.
Format documents across all disciplines and products. •
Collaborate with stakeholders to ensure document readiness. •
Create and verify bookmarks and hyperlinks for submission compliance. •
Support stakeholders with literature requests, including ordering, formatting, uploading, and approval. •
Report level publishing for all safety reports, clinical safety management plans, periodic safety reports, pharmacovigilance reports and investigational medicinal product dossier (IMPD), nonclinical reports via suitable publishing tools. •
Serve as the point of contact for supporting all stakeholders in eDMS-related questions. •
Contribute as the subject matter expert (SME) for assigned projects and represent the team in cross-functional, global, and project-related discussions. •
Generate fresh ideas to improve the team's efficiency and set exemplary standards. •
Utilize the latest tools introduced and provide constructive feedback to improve the efficiency and quality of work. Strategic Impact Ensure readiness of submission relevant documents to support product registration and lifecycle management, business continuity, and compliance with market and health authority requirements world-wide.
Collaborating across R&D functions to support basic to intermediate tasks under guidance from Submission Readiness experts. Cooperation •
Internally: International Regulatory Affairs (Regional Hubs), Regulatory CMC, Regulatory Lead (incl. US- and EU-Lead), Regulatory Project Manager, Global Patient Safety, Medical Writing, other RQS functions, Global Development Operations, R&D IT, Clinical functions, Non-clinical functions.
Externally: Regulatory vendors, CROs CANDIDATE’S PROFILE Education •
Graduate or Post Graduate background. • Good spoken and written English. Work Experience 1 of 2 RQS Operations JD Template.docx •
3 to 4 years of experience in Regulatory Affairs/Regulatory Operations environment • Competent authority or Academia/R&D experience related to the role Job specific Competencies & Skills • Executes tasks with team support, adheres to timelines, and communicates risks. Delivers high-quality outputs per Merck standards. • Skilled in eDMS, RIM, and related regulatory tools.
Understands their work's impact on the value chain and creates customer value. •
Invests in learning relevant technologies. • Demonstrate the ability to work independently and within a team. •
Possess active listening skills. •
Exhibit proactive behavior and self-accountability on tasks.
Who you are
Excellent written and spoken English.
Proficient in business communication and presentations. Actively networks within their specialization. Focuses on facts and quality, respects diverse viewpoints, and ensures everyone is heard.
Engages in cross disciplinary networking. •
Strong knowledge of Regulatory Affairs, post-approval changes, regulatory dossiers, and global procedures. Understands necessary documents for pharmaceutical registration and lifecycle management. Reviews and interprets regulatory guidelines to produce submission-ready deliverables. •
Understands business operations, makes informed decisions, and sees the big picture without missing details. •
Strong feedback orientation, with the ability to provide and receive constructive feedback at the appropriate time and in the appropriate context to improve team efficiency.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!