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...

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...

**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...

**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...

General Description: The Director, RIM is responsible for partnering with internal and external stakeholders in executing the RIM strategy and vision for the organization. This includes activities related to RIM resources, planning and budgeting (in partnership with IT), for key systems implementation/upgrade, monitoring and analysis of submission and...

**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...

Viatris Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

**Description** **JOB SUMMARY**: The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities...

**Your mission**: The Clinical Project Lead acts on behalf of the sponsor supervising all aspects of Clinical Trial activities for MoonLake’ sponsored clinical studies. The Clinical Project Lead in concert with the Clinical Development team, is accountable for achieving successful delivery of MoonLake´ clinical development activities at the project level...

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. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical...

**Description** **Senior Medical Writer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

**Description** **Senior Medical Writer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

Luminary Group is currently seeking a highly experienced and strategic-minded Chief Commercial Officer to join our client. As the Chief Commercial Officer, you will play a critical role in driving the commercial success of our life science consulting business, focusing on regulatory affairs (RA), pharmacovigilance (PV), quality assurance (QA), and...

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to...

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to...

**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** Other **Environmental Conditions** Office 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. Our distributed team of more than 100,000 colleagues delivers an outstanding combination...

The ‘Manager, Biologics Proposals - Existing Business’ is the process owner for all activities associated with planning for, generation of, and metrics around Biologics proposal generation (specifically Work Statements and/or Change of Scopes), specifically for supporting existing Client projects. - The Manager will lead a remote team supporting a global...