Description

Join our motivated team in Global Regulatory Affairs – New Assets and grow with exciting challenges. As Global Regulatory Lead (GRL) you are the primary interface and key strategic partner to Global Product Team (GPT) of throughout the product life cycle on New Assets and its maintenance. This will include the following activities:

  • Shaping regulatory strategies and submission plans related to new registrations or life cycle management and representing regulatory requirements worldwide

  • Creating high-quality documentation and carry out required registration procedures ensuring compliance and internal requirements

  • Ensuring and implementation of the necessary regulatory activities for the preparation and submission of applications for new registrations in accordance with the respective national regulatory requirements (e.g. local studies)

  • Leading the creation and maintenance of the Company Core Data Sheet (CCDS) for the assigned products as well as ensuring the necessary processes are followed

  • Ensuring and managing the answering of inquiries from the authorities

  • Implementation of necessary regulatory life cycle management activities (e.g. line extensions, annual reports, post-approval commitments, change control, renewals, import licenses, company registrations

  • Leading and coordinating regulatory projects as well as communication with the respective Merz representatives, partners or consultants as key regulatory member of the assigned Global Product Team (GPT)

  • Preparation and/or participation in scientific consultation with the regulatory authorities worldwide in close collaboration with the respective country RAM and other regulatory functions as appropriate

  • Support in the creation of benefit dossiers or health technology assessments, price and reimbursement applications, as well as due diligence procedures as applicable

  • Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage

  • At least 5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry

  • Very good knowledge of regulatory laws and regulations, including GMP and compliance aspects as well as CMC documents

  • Strong communication skills, also intercultural, including profound English (at least business fluent)

  • Strong problem-solving skills and analytical thinking ability

  • Team Player with performance orientation and persistence

  • 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 (€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 our more about our benefits here.