YOUR CONTRIBUTION
Join our motivated team in Global Regulatory Affairs and grow with exciting challenges. As Global Regulatory Lead (GRL), you will be the primary interface and key strategic partner to the Global Product Team (GPT) throughout the product lifecycle for Dermatology products. 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 regulatory standards.
* Leading the preparation and submission of applications for new registrations, ensuring adherence to national regulatory requirements (e.g., local studies).
* Managing the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products, ensuring process compliance.
* Responding to inquiries from regulatory authorities effectively.
* Implementing lifecycle management activities such as line extensions, annual reports, post-approval commitments, change controls, renewals, import licenses, and company registrations.
* Leading and coordinating regulatory projects and communicating with Merz representatives, partners, or consultants as a key member of the GPT.
* Participating in scientific consultations with regulatory authorities worldwide in collaboration with country RAMs and other regulatory functions.
* Supporting the creation of benefit dossiers, health technology assessments, pricing 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.
* Minimum of 5 years of professional experience in regulatory affairs within the pharmaceutical industry.
* Excellent knowledge of regulatory laws, GMP, compliance, and CMC documentation.
* Strong intercultural communication skills, including fluent English (business level).
* Strong problem-solving and analytical skills.
* Team-oriented with performance focus and persistence.
YOUR BENEFITS
* Opportunities for individual career development in a meaningful role—improving patients' quality of life.
* Hybrid work model supporting work-life balance.
* Modern workplaces in an attractive location with good transport links and a company restaurant.
* Global family business with flat hierarchies and an open, respectful culture.
* Competitive salary with extensive social benefits.
* Employer-subsidized benefits such as WellPass, Germany ticket, Corporate Benefits, and JobBike.
Learn more about our benefits here.
ABOUT US
Welcome to Merz Therapeutics, a leading pharmaceutical company dedicated to helping 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, value-driven company with 110 years of history, now a global innovator with products in over 90 countries.
Our goal is to improve treatment outcomes worldwide, reducing suffering for patients and their families.
Our commitment to research and development ensures we meet unmet patient needs with innovative treatments.
Join our international Merz Therapeutics family and help us achieve:
"BETTER OUTCOMES FOR MORE PATIENTS"
For more information, visit https://www.merztherapeutics.com/.
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