Regulatory Affairs Scientific Leader

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...

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...

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 therapies...

General DescriptionResponsible 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...

**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...

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...

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...

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...

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...

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...

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...

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 & FunctionKey Responsibilities Lead New Product Development for Medical Devices (including companion...

**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...

**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...

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

70-100% (con possibilità di job sharing), Berna e home officeTi occuperai delle seguenti attivitàFarai parte di un solido team dall'elevata visibilità manageriale, con cui elaborerai strategie e soluzioni per la Posta in un contesto normativo variegato e impegnativo. Ti confronterai e coordinerai spesso con le unità del gruppo della Posta e con il...

70-100% (con possibilità di job sharing), Berna e home officeTi occuperai delle seguenti attivitàFarai parte di un solido team dall'elevata visibilità manageriale, con cui elaborerai strategie e soluzioni per la Posta in un contesto normativo variegato e impegnativo. Ti confronterai e coordinerai spesso con le unità del gruppo della Posta e con il...

70-100% (con possibilità di job sharing), Berna e home officeTi occuperai delle seguenti attivitàFarai parte di un solido team dall'elevata visibilità manageriale, con cui elaborerai strategie e soluzioni per la Posta in un contesto normativo variegato e impegnativo. Ti confronterai e coordinerai spesso con le unità del gruppo della Posta e con il...