Global Regulatory Affairs Lead

vor 10 Stunden

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
{"h1": "Global Regulatory Affairs Lead", "p": "At Merz Therapeutics, we are seeking a highly skilled Global Regulatory Affairs Lead to join our team in Frankfurt am Main, Germany. As a key member of our Global Regulatory Affairs team, you will be responsible for shaping regulatory strategies and submission plans related to new registrations or life cycle management for our Neurotoxins products.

Your key responsibilities will include:

* Shaping regulatory strategies and submission plans related to new registrations or life cycle management
* Creating high-quality documentation and carrying out required registration procedures ensuring compliance and internal requirements
* Ensuring and implementing the necessary regulatory activities for the preparation and submission of applications for new registrations in accordance with the respective national regulatory requirements
* 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
* 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) Xeomin Movement Disorders
* 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

To be successful in this role, you will need:

* 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

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

At Merz Therapeutics, we offer a dynamic and supportive work environment, attractive remuneration, and a range of benefits including a hybrid work model, modern workplaces, and a company restaurant.

We look forward to receiving your application"}

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