Global Regulatory Lead (m / w / d) New Assets

Merz Therapeutics; Frankfurt; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Join a forward-thinking pharmaceutical company as a Global Regulatory Lead, where you will shape regulatory strategies and ensure compliance throughout the product lifecycle. This role offers the chance to work on new assets, lead regulatory projects, and collaborate with international teams to enhance patient outcomes. With a hybrid work model and a commitment to professional development, this position is ideal for someone looking to make a significant impact in the pharmaceutical industry. Be part of a family-owned company dedicated to improving lives through innovative treatments.

Leistungen

Career Development Opportunities

Hybrid Work Model

Company Restaurant

Employer-Sponsored Benefits

JobBike

Corporate Benefits

Qualifikationen

• 5+ years of experience in regulatory affairs in the pharmaceutical industry.
• Excellent knowledge of regulatory laws and compliance standards.

Aufgaben

• Shape regulatory strategies and submission plans for new registrations.
• Manage regulatory activities and respond to inquiries from authorities.

Kenntnisse

Regulatory Affairs

GMP Compliance

Analytical Skills

Communication Skills

Problem-Solving

Ausbildung

PhD in Pharmacy, Biology, or Chemistry

Bachelor's in Pharmacy, Biology, or Chemistry

Jobbeschreibung

Global Regulatory Lead (m / w / d) New Assets

View job here

Global Regulatory Lead (m / w / d) New Assets

Full Time

• With Professional Experience
• Start date: 7 / 4 / 24

YOUR CONTRIBUTION

Join our motivated team in Global Regulatory Affairs and grow with exciting challenges. As Global Regulatory Lead (GRL), you are the primary interface and key strategic partner to the Global Product Team (GPT) throughout the product lifecycle on New Assets and their maintenance. Your activities will include:

• Shaping regulatory strategies and submission plans related to new registrations or lifecycle management, representing regulatory requirements worldwide
• Creating high-quality documentation and carrying out registration procedures to ensure compliance with internal and external standards
• Managing regulatory activities for applications for new registrations according to national regulatory requirements (e.g., local studies)
• Leading the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products and ensuring process adherence
• Responding to inquiries from regulatory authorities
• Implementing lifecycle management activities such as line extensions, annual reports, post-approval commitments, change control, renewals, import licenses, and company registrations
• Leading and coordinating regulatory projects and communicating with Merz representatives, partners, or consultants as a key regulatory member of the GPT
• Participating in scientific consultations with regulatory authorities worldwide, collaborating closely with country RAM and other regulatory functions
• Supporting the creation of benefit dossiers, health technology assessments, price and reimbursement applications, and due diligence procedures as applicable

YOUR PROFILE

• Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field; a doctorate is advantageous
• At least 5 years of professional experience in regulatory affairs within the pharmaceutical industry
• Excellent knowledge of regulatory laws, GMP, compliance, and CMC documentation
• Strong communication skills, intercultural competence, and business-fluent English
• Strong problem-solving and analytical skills
• Team-oriented with performance focus and persistence

YOUR BENEFITS

• Opportunities for individual career development in a meaningful role that improves patients' quality of life
• Hybrid work model supporting work-life balance
• Attractive location with good transport links, modern workplaces, and a company restaurant (€4.13/menu)
• Global family business with flat hierarchies and an open, respectful culture
• Competitive salary with extensive social benefits
• Employer-subsidized benefits such as WellPass (€17.90/month), Germany ticket (€10/month), Corporate Benefits, and JobBike
• Learn more about our benefits here.

ABOUT US

Welcome to Merz Therapeutics, a leading pharmaceutical company dedicated to improving lives through innovative treatments for movement disorders, neurological and liver diseases, and other health conditions.

As a family-owned, value-driven company with 110 years of history, we serve patients in over 90 countries. Our mission is to enhance treatment outcomes worldwide, reducing suffering and improving quality of life.

Our commitment to research and development ensures we meet unmet patient needs with effective treatments. Join our international and motivated Merz Therapeutics family to help us achieve our goal: "BETTER OUTCOMES FOR MORE PATIENTS."