Finde einen Job 
Finde eine Ausbildung 
Top Arbeitgeber 
Top Universitäten 
Für Unternehmen Auf einen Blick
- Aufgaben: Lead and inspire the Global Regulatory Operations team while managing regulatory submissions.
- Arbeitgeber: Join Merz Therapeutics, a family-owned pharma leader improving lives for over 110 years.
- Mitarbeitervorteile: Enjoy hybrid work, career development, and perks like subsidized meals and wellness programs.
- Warum dieser Job: Make a real impact on patient lives in a supportive, innovative environment.
- Gewünschte Qualifikationen: Requires a degree in pharmacy or related field and 5+ years in Regulatory Affairs.
- Andere Informationen: Be part of a global team dedicated to better patient outcomes.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
YOUR CONTRIBUTION
As Head of Global Regulatory Operations (m/f/d) and member of the Global Regulatory Affairs Leadership Team, you contribute to the development and success of the Merz Therapeutics organization. You lead and develop our Global Regulatory Operations team and are responsible for the management of all activities around the technical creation, filing, and reporting of regulatory submissions. In this role, you act globally and work cross-functionally. Your main responsibilities include the following activities:
- Leading the Regulatory Operations Team : Motivating and developing team members and creating an inspiring team environment with an open communication culture.
- Monitoring and optimizing data entry and regulatory master data management : Managing data to ensure accurate regulatory reporting.
- Ensuring sufficient planning and execution of electronic submissions : Coordinating internal and external work packages and managing the budget to ensure all submissions are timely and within budget.
- Ensuring IDMP/SPOR requirements are met : Ensuring compliance with all relevant guidelines.
- Process and quality management : Taking responsibility for continuous process improvements and generating ideas for further digitalization projects to support regulatory processes within the department while ensuring high quality within the area of responsibility.
YOUR PROFILE
- University degree in pharmacy, chemistry, biology, biochemistry, or equivalent.
- At least 5 years of professional working experience in Regulatory Operations / Regulatory Affairs, ideally in a global environment.
- Leadership experience with a proven track record of successfully managing and inspiring teams.
- Knowledge in contract management and validation of computerized systems.
- Profound knowledge of common Regulatory Operations systems (RIMS, eDMS, eCTD Manager, eArchive), ticketing, and collaboration tools.
- Excellent communication skills in English.
- Proven ability to coordinate multiple projects/priorities and meet critical milestones.
- High level of leadership skills and change management competencies.
- Strong and effective communicator with a team-oriented working style.
YOUR BENEFITS
- Individual career development in a purposeful job: you improve patients\‘ quality of life!
- Hybrid work model that allows a good work-life balance.
- Attractive location with good transport links, modern workplaces, and a subsidized company restaurant (€4,13/menu).
- 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 (€17.90/month), Germany ticket (10€/month), Corporate Benefits, and JobBike.
Find out more about our benefits here .
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\“
#J-18808-Ljbffr
Head of Regulatory Operations (m/f/d) Global Regulatory Affairs Arbeitgeber: Merz Therapeutics
Kontaktperson:
Merz Therapeutics HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Head of Regulatory Operations (m/f/d) Global Regulatory Affairs
✨Tip Number 1
Make sure to highlight your leadership experience in your conversations. As a Head of Regulatory Operations, you'll need to inspire and manage a team effectively, so showcasing your ability to motivate others will be key.
✨Tip Number 2
Familiarize yourself with the specific regulatory systems mentioned in the job description, such as RIMS and eDMS. Being able to discuss your hands-on experience with these tools can set you apart from other candidates.
✨Tip Number 3
Prepare examples of how you've successfully managed multiple projects and met critical milestones in the past. This role requires excellent project coordination skills, so demonstrating your track record in this area will be beneficial.
✨Tip Number 4
Emphasize your commitment to continuous process improvement and digitalization. Share any relevant experiences where you've implemented changes that enhanced efficiency or quality in regulatory operations.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Head of Regulatory Operations (m/f/d) Global Regulatory Affairs
Tipps für deine Bewerbung 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Head of Regulatory Operations position. Tailor your application to highlight your relevant experience in regulatory affairs and leadership.
Highlight Leadership Experience: Emphasize your leadership skills and experience in managing teams. Provide specific examples of how you've motivated and developed team members in previous roles.
Showcase Technical Expertise: Detail your knowledge of regulatory operations systems and processes. Mention any experience with RIMS, eDMS, eCTD Manager, or similar tools that are relevant to the role.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the company's mission and values. Explain why you are passionate about improving patients' quality of life and how you can contribute to Merz Therapeutics' goals.
Wie du dich auf ein Vorstellungsgespräch bei Merz Therapeutics vorbereitest
✨Showcase Your Leadership Experience
As a candidate for the Head of Regulatory Operations, it's crucial to highlight your leadership experience. Share specific examples of how you've successfully managed and inspired teams in previous roles, focusing on your ability to create an open communication culture.
✨Demonstrate Your Regulatory Knowledge
Make sure to discuss your profound knowledge of Regulatory Operations systems such as RIMS, eDMS, and eCTD Manager. Be prepared to explain how you have utilized these tools in past projects to ensure compliance and optimize regulatory submissions.
✨Emphasize Project Management Skills
Given the role's focus on coordinating multiple projects, be ready to provide examples of how you've successfully managed competing priorities and met critical milestones. Discuss your approach to planning and execution, especially regarding electronic submissions.
✨Highlight Continuous Improvement Initiatives
Talk about your experience with process and quality management. Share specific instances where you've implemented continuous process improvements or contributed to digitalization projects that enhanced regulatory operations within your team.