Senior Regulatory Affairs Specialist

ResponsibilitiesThe German Regulatory Affairs Specialist will be responsible for ensuring the quality and regulatory compliance of our products and services in Germany, Austria, and Switzerland.A key aspect of this role is maintaining and managing the quality management system, ensuring compliance and efficiency across multiple franchises.The successful...

Safety LeadershipWe are looking for a Senior PV consultant to provide safety leadership to cross-functional project meetings and develop pharmacovigilance plans, risk evaluation and mitigation strategy plans, and risk management plans.ResponsibilitiesLead signaling review process and product Safety Signaling Team meetings.Provide safety input to...

Regulatory Affairs Manager (German Speaking) EMEA Recruitment is working with a well-established pharmaceutical business in its search for a German-speaking Regulatory Affairs Manager. Our client takes pride in quality in their portfolio, while improving the health of individuals globally. Based in Zug, the role offers hybrid working with a 50/50 model. The...

Description   The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional to assume a full-time employment position in Gilead's office in Zug, Switzerland in the capacity of  CMC   Regulatory Affairs Senior Manager ,...

Key Responsibilities:Act as the EU strategic partner for regulatory teams at BridgeBio affiliatesServe as the primary liaison between BridgeBio Affiliates and EMAProvide strategic regulatory direction for the registration and development of new products in the EUDevelop and execute EU-specific regulatory strategies, including management of orphan product...

About the Role: We are seeking a seasoned Regulatory Affairs expert to lead our EU strategy. As Senior Director, Regulatory Strategy, EU, you will be responsible for defining and implementing regulatory strategies for our products in the EU. You will work closely with Global Regulatory Leads to identify and mitigate regulatory risks, serve as the regional...

Senior Director, Regulatory Strategy, EU About BridgeBio BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and...

Senior Director, Regulatory Strategy, EUAbout BridgeBioBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the...

Position OverviewWe are looking for a Regulatory Affairs Professional to join our team at Randstad Switzerland. In this role, you will be responsible for managing the processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports.The successful candidate will work closely with vendors, the vendor oversight team, and the Quality...

Job DescriptionThis role involves overseeing the quality and regulatory activities of commercial offices and warehouses in Germany, Austria, and Switzerland.The successful candidate will be responsible for maintaining and managing the quality management system, ensuring compliance and efficiency across multiple franchises.A key aspect of this position is...

Job Description:This role involves high-level strategic planning and hands-on responsibilities to both define the product strategies and implementation of the regulatory strategy for the assigned products in the EU. The role will involve actively identifying the regulatory strategy for EU and managing regulatory oversight of any vendors involved in the...

Requirements:University Degree in Science or related discipline. A higher degree would be desirable, especially one specific to regulatory affairsExtensive knowledge and experience of working in one or more areas in regulatory affairs in the pharmaceutical industry or experience with a health authority for 10-15 yearsIdeally a combined mix of large company...

Job OverviewConsultys Suisse is seeking a Senior PV consultant to lead the signal management process, evaluate safety data and signals, and provide strategic input to regulatory documents.Key ResponsibilitiesLead the signal management process, including signal detection, tracking, documentation, and facilitating decisions regarding signals and safety...

Senior Manager Quality Assurance & Regulatory AffairsvVARDIS is a Swiss-based oral health company founded by Dr. Haleh and Dr. Golnar Abivardi, dentists, innovators, and award-winning entrepreneurs. vVARDIS is the result of a combined 30 years of dental and entrepreneurial experience, and 20 years of laboratory and clinical research paired with the creative...

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. This position is responsible for overseeing the Quality and Regulatory activities of the German, Austrian, and Swiss (DACH) commercial offices and warehouses, across to the several franchises of Smith+Nephew. The Quality & Regulatory Approval Specialist...

Responsibilities and SkillsThis is a comprehensive role that requires a strong analytical and problem-solving approach, as well as excellent communication skills.Key responsibilities include:Maintaining and enhancing our Quality Management System (QMS) in accordance with relevant regulations.Ensuring compliance across our portfolio of medical devices,...

Pharmacovigilance ExpertiseWe are seeking a Senior PV consultant with expertise in pharmacovigilance, regulatory affairs, and safety leadership to join our team.ResponsibilitiesEvaluate safety data and signals as part of ongoing pharmacovigilance activities.Develop and implement processes for responding to safety questions from regulatory authorities.Author...

Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both...

Safety Signal Specialist RoleWe are looking for a highly skilled Safety Signal Specialist to join our team at JobMarket.Duties:Develop and implement pharmacovigilance strategies to ensure compliance with regulatory requirementsLead signal management processes, including signal detection, tracking, documentation, and decision-makingEvaluate safety data and...

On behalf of our client, an international pharma company based in canton Zug, we are seeking a Senior PV Scientist.This role is fully remote (from Switzerland).In this role, you will serve as a global product lead for Pharmacovigilance activities within the Safety department including managing PV Scientist(s) assigned to products within the Senior PV...