Regulatory Affairs Scientific Leader

Are you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team! **Key Responsibilities**: - Provide strategic guidance on regulatory...

**Location: EMEA-Remote** **Division Summary**: The **ImmunoDiagnostics Division (IDD)** develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 2,000 employees worldwide, IDD is the global leader in in vitro allergy testing and also the European leader...

Job Description Summary: Founded in 1998, PTC Therapeutics is a global biopharmaceutical company focused on discovery, development and commercialization of innovative treatments that bring benefits to patients suffering from rare diseases. For more than 25 years, PTC have been harnessing its scientific platforms to deliver a number of life-changing...

**Key Responsibilities**: - Coordinate projects beginning to generate supporting evidence for NGS utilization in Oncology (Clinical Validity/Utility studies); - Develop and facilitates investigator sponsored trial/studies while supervising progress and adherence to timelines, commitments, results and obligations approved projects; - Support the design of...

**Job Description Summary**: Executive Director, Global Medical Affairs, Global Gene Therapy Lead **Job Description**: The Executive Director, Global Medical Affairs - Global Gene Therapy Lead is responsible for defining the Global Medical Affairs vision, strategy and tactics to support PTC’s Gene Therapy business. He/she will partner with the Regional...

General Description Responsible for strategic and operational regulatory support of BeiGene’s entry into our new market territories worldwide, with dotted reporting line to the Head of New Markets (i.e. LATAM, MENA, Eastern Europe and Africa). Accountable for managing the assigned regulatory affairs teams to drive the regulatory activities of all BeiGene...

General Description: BeiGene is seeking a highly motivated and fast-learning person to support the expansion of new markets and the EU clinical trial regulations. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The...

**Role & Function** The Medicine Development Leader has the overall responsibility for bringing and representing the clinical and the medical strategy for the assigned product to the Core Asset Team (CAT), including benefit / risk evaluation, PV and Safety. **Key Responsibilities** - Provides medical and scientific expertise and perspective to inform asset...

**Key Responsibilities** - Lead New Product Development for medical devices (including companion diagnostics) and drug/device combination products to ensure compliance when placed on market - Manage the creation and maintenance of regulatory documentation to support compliance including device technical files - Provide expert advice to internal and external...

**The job**: As our new **Sr Market Development Manager** you will be joining our ImmunoDiagnostics Division (IDD) and will be responsible for executing the Market Development strategy and delivering on key initiatives for the IDD Portfolio in Western Europe, in collaboration with Regional Marketing, HEOR, Scientific & Medical Affairs and Commercial. The...

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...

**Position Summary**: We are looking for an** Associate Director, Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) **to join our team. We are expanding our existing group of exceptionally talented and well-motivated colleagues to provide regulatory CMC support for the development and commercialization of our products. This position will be...

**Position Summary**: We are looking for an** Associate Director, Regulatory Affairs CMC **to join our team. We are expanding our existing group of exceptionally talented and well-motivated colleagues to develop and commercialize This position will be responsible for developing and executing CMC regulatory strategies to support the expansion into...

You will also take charge if strategic direction and the oversight of global and local cross-functional CMC teams across a number of areas, in order to define and deliver contemporary CMC packages across life cycle management, market authorisation and clinical development. Your expertise in biologics and process validation will be crucial in maintaining...

We are looking for a dedicated new Scientific Affairs team member to take the role of Associate Director Scientific Communications pegcetacoplan, starting immediately. This role is a permanent position that will be based or report to the Stockholm Headquarter office, and will report to Emmelie Persson, Senior Director Head of MACS pegcetacoplan The...

We are looking for a passionate and driven Science Lead to help develop and test SenopiVR’s new medical device, SenopiMed. SenopiMed provides cognitive therapies and cognitive tests to seniors using virtual reality (VR). We are still in the early stage of an exciting journey to improve the quality of life of many seniors by providing more scalable...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Position Overview** The Associate Director, Clinical Development Science provides clinical development expertise into a multi-disciplinary team engaged in advising clients in early through late-stage development of medical products. Inpout will be provided into the design and...

**Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of rare disease patients. and our edge comes from our team of people. **Role & Function** **Key Responsibilities** - Lead New Product Development for Medical Devices (including...