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- Aufgaben: Lead regulatory affairs for medicinal products, ensuring compliance and managing documentation.
- Arbeitgeber: Join Merz Therapeutics, a global leader in improving patient quality of life through innovative treatments.
- Mitarbeitervorteile: Enjoy a hybrid work model, attractive remuneration, and various employer-subsidized perks.
- Warum dieser Job: Make a real impact on patients' lives while working in a supportive, family-oriented culture.
- Gewünschte Qualifikationen: PhD preferred; 3-5 years in regulatory affairs with strong communication and analytical skills required.
- Andere Informationen: Be part of a dedicated team focused on better outcomes for patients worldwide.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
YOUR CONTRIBUTION
As a Senior Regulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. This will include the following activities:
- CMC Documentation: Create, review, and update high-quality CMC documentation to obtain and maintain product approvals, ensuring compliance with global regulatory requirements; support the creation of IMPDs for clinical trial applications.
- Change Control: Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status.
- Response Management: Handle and manage inquiries related to quality documentation from authorities, ensuring timely and accurate responses.
- Project Coordination: Oversee regulatory CMC projects, communicate with Merz representatives and partners, and coordinate third-party services.
- Regulatory Strategy: Develop regulatory CMC strategies and represent regulatory requirements in project teams and interdisciplinary teams.
- Regulatory Intelligence: Maintain a detailed understanding of global and national CMC regulatory requirements and best practices.
YOUR PROFILE
- Completed scientific studies in Pharmacy, Biology, Chemistry or a related field of studies; a doctorate is an advantage.
- 3-5 years in regulatory affairs or in a department responsible for CMC matters, such as analytics, development, or quality control.
- Strong communication skills, including proficiency in English.
- Analytical and systemic thinking.
- Strong negotiation skills and teamwork.
- Solution-oriented with a focus on compliance and quality.
YOUR BENEFITS
- Individual career development in a purposeful job: you improve the quality of life of our patients!
- Hybrid work model that allows a good work-life balance.
- Attractive location with good transport links, modern workplaces, and a company restaurant.
- Global family business with flat hierarchies and an open, respectful corporate culture.
- Attractive remuneration with extensive social benefits.
- Variety of employer-subsidized benefits such as WellPass, Deutschland-ticket, Corporate Benefits, and JobBike.
For more information, visit .
ABOUT US
Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases, and other health conditions regain their quality of life.
We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.
Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.
Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.
Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: \“BETTER OUTCOMES FOR MORE PATIENTS\“ .
Viktoria Becker Talent Acquisition Partner
#J-18808-Ljbffr
Senior Regulatory Affairs Manager (m/f/d) CMC Arbeitgeber: Merz Therapeutics
Kontaktperson:
Merz Therapeutics HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Regulatory Affairs Manager (m/f/d) CMC
✨Tip Number 1
Familiarize yourself with the latest global regulatory quality requirements, especially those related to CMC documentation. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in regulatory affairs and CMC roles. Attend industry conferences or webinars to connect with others in the field, which can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed change control processes or handled inquiries from authorities in your previous roles. Real-life scenarios can showcase your problem-solving skills and experience.
✨Tip Number 4
Research Merz Therapeutics thoroughly, including their products and corporate culture. Understanding their mission and values will allow you to tailor your conversations and show how you align with their goals.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Regulatory Affairs Manager (m/f/d) CMC
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Senior Regulatory Affairs Manager position. Highlight your relevant experience in CMC documentation, change control processes, and regulatory strategy in your application.
Tailor Your CV: Customize your CV to emphasize your 3-5 years of experience in regulatory affairs or related fields. Include specific examples of your work with CMC matters, showcasing your analytical skills and solution-oriented approach.
Craft a Compelling Cover Letter: Write a cover letter that reflects your passion for improving patient outcomes and your alignment with Merz Therapeutics' values. Discuss how your background in pharmacy, biology, or chemistry makes you a strong candidate for this role.
Highlight Communication Skills: Since strong communication skills are essential for this role, provide examples of how you've effectively communicated with regulatory authorities or managed inquiries related to quality documentation in your previous positions.
Wie du dich auf ein Vorstellungsgespräch bei Merz Therapeutics vorbereitest
✨Showcase Your Regulatory Knowledge
Be prepared to discuss your understanding of global regulatory quality requirements. Highlight specific experiences where you successfully navigated CMC documentation and compliance processes.
✨Demonstrate Change Control Experience
Share examples of how you've implemented change control processes in previous roles. Discuss your approach to coordinating regulatory assessments and maintaining submission statuses.
✨Communicate Effectively
Strong communication skills are essential for this role. Practice articulating complex regulatory concepts clearly and concisely, as well as your ability to manage inquiries from authorities.
✨Highlight Teamwork and Project Coordination Skills
Prepare to discuss your experience in overseeing regulatory CMC projects and collaborating with interdisciplinary teams. Emphasize your negotiation skills and solution-oriented mindset.
