Global Regulatory Affairs Manager

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Global Regulatory Lead (m/w/d) New Assets
  • Full Time
  • With Professional Experience

YOUR ROLE

As the Global Regulatory Lead, you will serve as the primary liaison and strategic partner to the Global Product Team (GPT) throughout the product lifecycle for New Assets. Your responsibilities will encompass:

  • Developing regulatory strategies and submission plans for new registrations and lifecycle management, ensuring alignment with global regulatory requirements.
  • Producing high-quality documentation and executing necessary registration processes to guarantee compliance with internal and external standards.
  • Overseeing the implementation of regulatory activities for the preparation and submission of applications for new registrations, adhering to national regulatory requirements.
  • Leading the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products, ensuring adherence to established processes.
  • Managing inquiries from regulatory authorities effectively.
  • Coordinating regulatory lifecycle management activities, including line extensions, annual reports, and post-approval commitments.
  • Directing regulatory projects and facilitating communication with Merz representatives, partners, or consultants as a key regulatory member of the assigned GPT.
  • Participating in scientific consultations with regulatory authorities globally, in collaboration with country RAM and other relevant regulatory functions.
  • Assisting in the development of benefit dossiers, health technology assessments, and reimbursement applications as needed.

YOUR QUALIFICATIONS

  • Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field; a doctorate is advantageous.
  • A minimum of 5 years of professional experience in regulatory affairs within the pharmaceutical sector.
  • Comprehensive knowledge of regulatory laws and regulations, including GMP and compliance aspects, as well as CMC documentation.
  • Excellent communication skills, including intercultural proficiency and strong command of English (business fluent).
  • Exceptional problem-solving abilities and analytical thinking skills.
  • A collaborative team player with a focus on performance and perseverance.

YOUR ADVANTAGES

  • Opportunities for individual career development in a meaningful role that enhances patient quality of life.
  • Flexible hybrid work model promoting a healthy work-life balance.
  • Modern work environment with excellent transport links and on-site dining options.
  • A family-owned global business with a culture of openness and respect.
  • Competitive compensation package with extensive social benefits.
  • A range of employer-subsidized perks, including wellness programs and transportation benefits.

ABOUT MERZ THERAPEUTICS

Merz Therapeutics is a leading pharmaceutical company dedicated to improving the quality of life for individuals with movement disorders, neurological diseases, liver diseases, and other health conditions. As a family-owned and value-driven organization, we have been committed to meeting patient needs for over a century and are recognized as a global leader in innovation with products available in more than 90 countries.

Our mission is to enhance treatment outcomes for patients worldwide, alleviating the burden of suffering for those affected and their families. We are devoted to continuous research and development to identify unmet patient needs and provide effective treatments.

Join us in our mission for BETTER OUTCOMES FOR MORE PATIENTS.

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