Head of Regulatory Affairs Emea
Il y a 3 mois
For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA.
argenx
argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, we translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.
For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA
- PURPOSE OF THE ROLE
The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute to build and grow the organization across the region. The individual will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization at a regional and country level across the region. In close collaboration with other functional heads and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, distribution, and post-approval regulatory activities, among others.
ROLES AND RESPONSIBILITIES:
- An important aspect of the role is to work with the Global Head of Regulatory to develop and implement infrastructure and process improvements to enhance the efficiency of the Global RA organization with a view to enabling more simultaneous submissions.
- Establish the EMEA regulatory strategy for marketed and pipeline products and ensure it is in line with the global regulatory strategy, taking into account the diverse needs of the EMEA region
- Perform or oversee the preparation of the registration dossiers and adequate response to all agency questions
- Ensure the labelling components relevant to the region are based on the company core datasheet and prepared in conjunction with the EMEA team
- Secure regulatory approvals within the EMEA region, on time as per plan, ensuring cross-functional partners are fully aware of procedures and timelines to guarantee organizational readiness
- Proactively seek out robust cross-functional input to help inform decision-making and appropriate trade-offs regarding labelling, procedural steps, and overall probability of regulatory success
- Collaborate with supply chain, CMC, distribution, and market access colleagues to ensure regulatory strategies are aligned with broader organizational strategies
- Monitor regulatory approvals, trends, and dynamics in clinical areas of interest to the company, and proactively share regulatory intelligence internally, as appropriate
- Provide strategic, operational and tactical regulatory insight on pre-approval activities, including EAP development and roll-out
- Serve as the regulatory affairs business partner to local commercialization teams on all matters related to product promotion and materials review
- Partner with medical, legal, quality, PV, market access and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
- Ensure alignment between business strategy within the EMEA team and the broader global regulatory strategy and development teams
- Support the EMEA business in all other regulatory-related activities, this includes local regulatory activities in individual member states, where needed.
- Oversee regulatory affairs vendors involved in filings and help ensure high quality interactions with the EMA and other EMEA agencies
- Lead and develop the EMEA regulatory team.
SKILLS AND COMPETENCIES:
- Prior experience in the build-out of organizations and the creation of regulatory infrastructure to support commercialization from scratch
- A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of and monitoring of the evolving landscape of regulations and guidelines, specifically in Europe, Middle East and Africa
- Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines in Europe, including direct experience leading end-to-end regulatory submissions
- Affinity with science and ability to interact with scientists and clinicians, internally and externally
- Direct experience interacting with regulatory authorities across EMEA, and a successful track record of interactions among regulatory agencies
- A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills in English and at least one other major EU language, to succeed within a multi-cultural and multi-lingual global environment
- Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilit
-
Head of Regulatory Affairs EMEA
il y a 4 semaines
Gent, Belgique Argenx Temps pleinFor the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, we translate immunology breakthroughs into a world-class...
-
Head of Regulatory Affairs Emea
Il y a 8 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. PURPOSE OF THE ROLE The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute...
-
Head of Regulatory Affairs
il y a 4 semaines
Gent, Belgique Hudson Belgium Temps pleinFunction The Head of Regulatory Affairs and Quality Assurance is a key member of our regional Benelux team, reporting to our General Manager Belgium & Luxembourg and the General Manager Netherlands. You will be responsible for overseeing and leading the RQ Department and associated activities across the BeNeLux cluster. You will provide regulatory and...
-
Head of Cmc Ra
il y a 1 mois
Gent, Belgique Argenx Temps pleinThe Head of CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs will lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial phases. This role plays a critical part in ensuring compliance with global regulatory requirements while...
-
Regulatory Affairs Specialist
Il y a 6 mois
Gent, Belgique Jefferson Wells Temps pleinLocation: **Gent** **#23587** **Regulatory Affairs Specialist** Vast Contract - Regio Gent **#regulatory #affairs #specialist #food** Beschik je over een masterdiploma met een voorkeur voor een specialisatie in landbouw, voeding of chemie? Heb je min. 3 jaar ervaring in Regulatory Affairs? Ben je zelfstandig, zeer communicatief en computervaardig? Lees...
-
Emea Commercial and Medical Affairs Operations Lead
Il y a 6 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our Business Information Systems (BIS) team, argenx is looking for an EMEA (Europe, Middle East and Africa) Commercial and Medical Affairs Operations Lead. The Lead will be a key member of the BIS Commercial and Medical affairs team and will act as the Digital, Process and Technology business partner for the EMEA Commercial and Medical...
-
junior Regulatory Affairs Specialist
Il y a 8 mois
Gent, Belgique Elements Advisory Temps pleinAs a Junior Regulatory Affairs Specialist, you will be responsible for assisting in the management of regulatory affairs activities related to our biocide products. You will collaborate closely with the regulatory affairs team and other cross-functional departments to ensure compliance with relevant regulations and standards. **Responsibilities**: - Assist...
-
Head of Post-marketing Cmc Regulatory
Il y a 6 mois
Gent, Belgique Argenx Temps pleinKey Accountabilities and Responsibilities: Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to other territories world-wide. Critical to this role are strong CMC regulatory strategy and...
-
Regulatory Affairs Officer
Il y a 6 mois
Gent, Belgique Cooper Consumer Health Temps pleinRequisition ID - 39 - Job Family 1- Regulatory & PSRM - Country 1- Belgium - Location 1- Hybrid - About us - **Cooper Consumer Health** is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) products with strong brands such as Valdispert, Oenobiol, Excilor, Vitascorbol, Lashyle and...
-
Senior Regulatory Affairs Specialist
Il y a 8 mois
Gent, Belgique Elements Advisory Temps pleinAs a Senior Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for biocide products. You will work closely with cross-functional teams, regulatory authorities, and external partners to facilitate the registration and approval processes for biocide products in different markets. Your expertise in...
-
Regulatory Affairs Specialist Crop Protection
Il y a 6 mois
Gent, Belgique Eastman Temps plein**The job**: We are looking for a Regulatory Affairs Specialist to support the global product stewardship and regulatory affairs Crop Protection team. In close collaboration with business, technology and product management, you give support in protecting the existing portfolio of products and actively engage in projects to extend our growth worldwide. This...
-
Senior Associate Regulatory Affairs
Il y a 6 mois
Gent, Belgique Perrigo Temps plein**Description Overview**: We are excited to be recruiting for an Senior Associate in Regulatory Affairs to be based in either Ghent, Rotterdam, London or Paris. Paris, France or Ghent working on our exciting Medical Device Portfolio. The main responsibilities of the role will be to work on a diverse range of Regulatory Affairs projects to meet business...
-
Senior Manager
Il y a 6 mois
Gent, Belgique BIVMB Temps plein**WHO ARE WE?**: At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 53,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have...
-
Head of Regulatory Science Seeds
il y a 3 semaines
Gent, Belgique BASF Belgium Coordination Center CommV Temps plein**WELCOME TO BASF**: Agriculture plays a fundamental role in fulfilling many of humanity’s basic needs: food, feed, energy. To support growers and those who take care of our environment, BASF develops innovative solutions for farming, pest-, disease - and weed control so that we can effectively contribute to improving people’s lives and business’...
-
EMEA BIS Operations lead
il y a 4 semaines
Gent, Belgique Argenx Temps pleinEMEA BIS Operations lead - Commercial and Medical For the expansion of our Business Information Systems (BIS) team, argenx is looking for an EMEA (Europe, Middle East and Africa) BIS Operations lead - Commercial and Medical. The Lead will be a key member of the BIS Commercial and Medical affairs team and will act as the Digital, Process and Technology...
-
Associate Director/director, Regulatory
Il y a 6 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, argenx, based in Europe, to support the rapid growth needed for successful commercialization. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs is a key member of the global regulatory team. This role...
-
QA Project Manager, Car-t Emea
Il y a 2 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a QA Project Manager for the CAR-T hub in Europe. The position will be based in Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and...
-
Head of Downstream Processing
il y a 1 mois
Gent, Belgique Those Vegan Cowboys Temps pleinAre you a protein science buff, with a hankerin’ for the fine art of cheese-makin’? Come to Ghent! The Downstream Processing (DSP) posse at Those Vegan Cowboys is on a mission to corral and purify microbial caseins, to make ‘em shine in the cow-free cheese of future generations. Our team rides hard, refining and understanding these proteins so...
-
Head of Downstream Processing
il y a 4 semaines
Gent, Belgique Flanders.bio Temps pleinVacancy Are you a protein science buff, with a hankerin’ for the fine art of cheese-makin’? Come to Ghent! The Downstream Processing (DSP) posse at Those Vegan Cowboys is on a mission to corral and purify microbial caseins, to make ‘em shine in the cow-free cheese of future generations. Our team rides hard, refining and understanding these proteins...
-
Regulatory Intelligence Mgr, Global Ra
Il y a 4 mois
Gent, Belgique Argenx Temps pleinRoles and Responsibilities: - Identify and permanently monitor the information needs of the internal stakeholders. - Participate in the external environment parsing, extracting relevant information. - Analyze and interpret changes to the regulatory landscape. - Keep up to date with latest guidelines from Health Authorities e.g.: EMA, MHRA, FDA, PMDA and...