Global Regulatory Lead / Senior Global Regulatory Affairs Manager for Reproductive Medicine & Maternal Health and Urology/Uro-Oncology
Ferring
Job Description:Are you an experienced Regulatory Affairs Professional, and do you want to help drive the development of the current and next generations of Ferring’s health care solutions that help people live better lives?Then come join us in a challenging position in one of our Global Regulatory Affairs Therapeutic Area teams.Ferring is dedicated to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas.Our comprehensive approach encompasses a diverse range of treatment solutions. We strive to lead in innovation and adopt a global perspective, starting from the early stages of development.We invite you to leverage your extensive regulatory expertise to drive the progression of our development projects and/or key marketed products within these fields. In return, we offer you the freedom to impact our ways of working and expand your personal toolkit along the way.
We offer an exciting job in a company with an entrepreneurial and inclusive work environment and great opportunities to develop. At Ferring, People come first. Your contributions will be valued, and your efforts will make a true impact on the business and for the many people in need of health care solutions within our therapeutic areas. You will work in an international environment in a global HQ capacity and enjoy close collaboration with colleagues across the global functions and in our regional and affiliate offices.Ferring+YouIn your role you will work in a team of highly skilled regulatory professionals responsible for the global regulatory activities for our development projects and marketed products. In the Therapeutic Area Teams, we have the overall responsibility for developing and executing the global regulatory strategies, including worldwide submission planning, market expansions and label expansions.Your day at FerringReporting to the Senior Director in the Therapeutic Area team, you will be assigned to one or more projects or marketed products, and your responsibilities may encompass the following:Represent GRA in the Global Project Team and chair the Global Regulatory Teams providing regulatory strategic expert input to drive project/product progressionDrive the development of high-quality global regulatory strategies, including identifying regulatory opportunities and mitigation of risks, strategic submission and regulatory activity planning, and development of competitive labels in collaboration with relevant team members and stakeholders.Plan and manage meetings with health authorities worldwide for the projects/products assigned. Drive and lead the preparation of high-quality briefing packages, liaising with health authorities and experts to obtain scientific advice to mitigate regulatory risks and enable project progression.For late-stage projects, ensure submission and approvals of BLAs/MAAs in US, EU, Japan, China and other countries worldwide in collaboration with local regulatory colleagues, and drive the strategic planning of market expansions, including responses to authority inquiries.For marketed products, prepare the regulatory LCM strategy and manage the strategic planning and execution of regulatory submissions and approvals for worldwide market expansions, renewals, and variations for the products assigned, leading the submission team and chairing the Labelling Management TeamEnsure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide input to clinical and nonclinical documentation and represent GRA in our Clinical Development, Safety Management teams, and/or Clinical Trial Team
Kastrup, Hovedstaden
Sat, 10 Aug 2024 06:37:43 GMT
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