Global Regulatory Medical Device, Combination

**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...

**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...

**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...

As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Develop regulatory documents for submission to regulatory agencies globally, including **Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and...

**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...

**Your mission**: As a (Senior) Medical Writer, you are an integral part of MoonLake’s Clinical Development team responsible for providing medical writing support to our clinical development programs including preparation, development, review, revision and finalization of clinical, medical and regulatory documents for submission to external stakeholders...

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...

**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...

**Summit Therapeutics (Summit) Mission** **Summit Activities** We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We initiated phase-III clinical...

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...

**Description** Here at Syneos Health, we are looking for an **Executive Medical Director to work sponsor dedicated. **You will have the chance to work in exciting studies in Oncology. The job location is** Home Based in France or Netherlands.** **Summary** This position is responsible for providing leadership and establishing strategy and implementing...

. General Description: A great opportunity to join BeiGene in an early stage of establishment, where you can contribute to the start of something great! We are looking for a passionate and empathic colleague, with an entrepreneurial mindset who dares to challenge the status quo and who can and wants to bring innovative haemato-oncological medicines to the...

**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...

Job Introduction Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC. Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. Here...

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...

General Description: - The Global Clinical Compliance Lead (gCCL) is responsible for implementing the global clinical compliance and inspection management strategy across BeiGene clinical programs at study level, as assigned. The gCCL provides compliance and quality support to BeiGene GCO study teams for the assigned programs / studies and ensures that...

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...

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...

**Description** **Medical Editor II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...