Regulatory Affairs Application Support
vor 2 Monaten
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC, and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change.
Responsibilities- Provide application support to key users for the eDMS, RIMS, and eSM platforms (e.g., business functional operations, high-level data analytics, data management, change management).
- Work with IT and external vendors to troubleshoot technical issues and coordinate system updates.
- Support system data management activities, e.g., master data management, data quality, security and integrity, preparation and implementation of data-related changes.
- Technically support the handling of operative master data, operative business units, and regulatory units.
- Create and maintain all User Requirement Specifications and Quality Control documents as required by SOPs and Processes.
- Analyse, manage, and align on solution releases e.g., process and data requirements, as well as design, test scripts authoring, and execution.
- Lead business operations impact assessments and industry best practices implementation.
- Federate the user community proactively engaging on new regulatory changes being implemented in the eDMS, RIMS, and eSM systems.
- Bachelor’s or higher degree in a scientific discipline (e.g., computer science, information systems, engineering, mathematics, natural sciences, medical, or biomedical science).
- Knowledge of systems in the Regulatory Affairs domain, incl. Regulatory Information Management, electronic Document Management and Publishing Management systems with demonstrated experience in managing support and demand needs for these systems.
- Extensive knowledge of Regulatory Affairs (GRA) business domain and GRA business processes & data management.
- Ability to understand complex functional requirements/requests from business users and translate them into pragmatic and workable (technology) solutions.
- Familiar with regulatory data standards - IDMP/XEVMPD.
- Strong agile process management mindset and ability to provide customer-facing support to identify value drivers and continuous improvement of processes and solutions.
- Some working experience in the Regulatory Affairs area might be beneficial.
I want to apply for the following position.
#J-18808-Ljbffr-
Regulatory Affairs Application Support Consultant
vor 7 Monaten
Basel, Schweiz Arcondis VollzeitABOUT ARCONDIS Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and...
-
International Regulatory Affairs Intern
vor 6 Monaten
Basel, Schweiz Mirum Pharmaceuticals Vollzeit**MISSION**: **Job Summary**: As an Intern in Regulatory Affairs International team, you will work closely with the regulatory affairs team to ensure compliance with applicable regulations, standards, and guidelines governing the development, manufacturing, and marketing of pharmaceutical products. This entry-level position provides an excellent opportunity...
-
Regulatory Affairs Director
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitJob Description for Regulatory Affairs Director at Ironwood PharmaceuticalsResponsibilities and Expectations Develop and lead global regulatory strategies for assigned projects or products across all phases of product development, ensuring timely development and implementation. Participate in or lead cross-functional task forces and initiatives,...
-
Regulatory Affairs Expert
vor 1 Monat
Basel, Basel-Stadt, Schweiz Straumann Group VollzeitJob Summary:As a Regulatory Affairs Expert at Straumann Group, you will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in compliance with applicable regulatory requirements.Main Responsibilities:Ensure product compliance with regulatory requirementsInteract with authorities and other approving bodiesGuide...
-
Regulatory Affairs Team Lead
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Straumann Group VollzeitJob Title: Regulatory Affairs Team LeadAbout the Role:We are seeking a highly skilled Regulatory Affairs Team Lead to join our team at Straumann Group. The successful candidate will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in accordance with applicable regulatory requirements.Main Responsibilities:*...
-
Entry Position Medical Writing
Vor 2 Tagen
Basel, Schweiz SFL Regulatory Affairs & Scientific Communication VollzeitWould you like to join and contribute to an award-winning, successful and growing multi-cultural organization in the heart of Europe and a world-leading region of the pharmaceutical industry? SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from...
-
Regulatory Affairs Director
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitKey Responsibilities:As a crucial member of Ironwood Pharmaceuticals' Regulatory Affairs team, you will develop and implement global regulatory strategies for assigned projects and products, ensuring timely development and submission of regulatory materials. Your expertise will help navigate complex regulatory landscapes, drive strategic planning, and foster...
-
Regulatory Affairs
vor 7 Monaten
Basel, Schweiz Straumann Group Vollzeit**Job Purpose** Be a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada. **Main Tasks and Responsibilities** - Support product development process and ensure compliance of deliverables - Compile...
-
Entry Position Quality Assurance
Vor 2 Tagen
Basel, Schweiz SFL Regulatory Affairs & Scientific Communication VollzeitWould you like to join and contribute to an award-winning, successful and growing multi-cultural organization in the heart of Europe and a world-leading region of the pharmaceutical industry? SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from...
-
Regulatory Affairs Manager
vor 1 Monat
Basel, Schweiz Boehringer Ingelheim (Schweiz) GmbH VollzeitInnovative Medikamente für Mensch und Tier: Dafür steht das forschungsbasierte Pharmaunternehmen Boehringer Ingelheim seit über 130 Jahren. Boehringer Ingelheim zählt zu den 20 führenden Unternehmen der Branche und ist auch heute noch ein Familienunternehmen. Jeden Tag schaffen rund 52.000 Mitarbeiter Werte durch Innovation in den drei...
-
Quality Assurance
Vor 2 Tagen
Basel, Schweiz ALTOGEN AG Vollzeit**Quality Assurance & Regulatory Affairs (QA/RA) Manager - Medical Devices** ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas...
-
Head of International Regulatory Affairs
vor 6 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitResponsibilities: Develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans; Participate in or lead departmental and cross-functional task forces and initiatives; Demonstrate...
-
International Regulatory Affairs Manager
vor 7 Monaten
Basel, Schweiz Sobi Vollzeit**Company Description** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. One...
-
Global Regulatory Affairs Manager
Vor 2 Tagen
Basel, Schweiz EDP Personalberatung Vollzeit**#Pharma #RegulatoryAffairs***: Our customer, a **pharmaceutical company based near Basel**, needs reinforcement. For a **temporary employment** **, **we are looking for a **Global Regulatory Affairs Manager (M/F/d), 100%**: **Jetzt bewerben** **Major accountabilities**: - Lead the joint efforts for the development of the global product approval...
-
Regulatory Affairs Project Manager
vor 3 Monaten
Basel, Schweiz Alira Health VollzeitJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Regulatory Affairs Manager
Vor 2 Tagen
Basel, Schweiz Proclinical VollzeitProclinical are working alongside a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis. The opening position is for a Regulatory Affairs Manager. For more information, please get in touch now! **Responsibilities**: - Conduct regulatory evaluations for aberrations and change control. -...
-
Director, Global Regulatory Affairs
vor 6 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...
-
Director, Global Regulatory Affairs
vor 6 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...
-
Global Regulatory Affairs Leader
vor 1 Monat
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitJob SummaryWe are seeking a highly experienced and skilled Global Regulatory Affairs Leader to join our team at Ironwood Pharmaceuticals. In this role, you will be responsible for developing and implementing regulatory strategies across all phases of product development, ensuring timely development of regulatory strategy and operating plans.
-
Team Leader Regulatory Affairs
vor 7 Monaten
Basel, Schweiz Straumann Group Vollzeit**Job Purpose** As Team Leader Regulatory & Compliance - Regenerative Solutions, you will be part of a small but highly motivated and very international team, dedicated to our regenerative product portfolio. With your regulatory and compliance knowledge, you will support product developments and life cycle activities for the regenerative portfolio in order...