Associate Director/director Regulatory Affairs
il y a 2 semaines
For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, based in Europe, to support the rapid growth needed for successful commercialization. The role will report into the Global Head of Regulatory Affairs.
Key Accountabilities and Responsibilities:
The Associate Director/Director Regulatory Affairs is a key member of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute to developing sound regulatory strategies globally. The role will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization. In close collaboration with other functions 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.
Your primary areas of focus are:
- Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activities globally
- Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings
- Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators
- Working with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requested
- Monitor, interpret, and communicate changes to the global regulatory landscape as required
- Serve as the regulatory affairs business partner to local commercialization teams
- Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
- Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams
Desired Skills and Experience:
- Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA
- PhD or PharmD preferred
- Prior experience working in rapidly growing pharmaceutical organizations is desirable
- A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines, specifically in United States
- Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA
- Affinity with science and ability to interact with scientists and clinicians
- Experience interacting with regulatory authorities, especially the FDA and EMA
- Ability to speak and interact with a diverse group of individuals on technical and business topics
- Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally
- Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization
- A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
- Track record of successful interactions with regulatory and health authorities
- You are a connector, building relationships and partnering across the organization to achieve the company goals
- You excel in a fast-paced, results-driven, highly accountable environment
- You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done
- You show strong leadership with proven ability to build, motivate and develop a team
- You resonate with the values of argenx and you are ready to drive the Company Culture
- You combine strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goal
-
Associate Medical Director Neurology Emea
il y a 5 jours
Gent, Belgique Argenx Temps pleinThe EMEA Associate Medical Director Neurology is a medical and scientific expert on argenx’s scientific data, products and trials, and will support and oversee execution of the EMEA Medical Affairs plans for Neurology indications, in very close collaboration with EMEA country medical affairs teams to ensure excellence in execution of medical affairs...
-
(Associate) Director Bioanalytics, Franchise Lead
il y a 4 jours
Gent, Belgique Argenx Temps pleinFor the expansion of the bioanalytical team, argenx is looking for a (Associate) Director Bioanalytics, with profound experience in late-stage drug development of large molecules. The level and title will depend on the experience of the incumbent. He/she will conduct and lead bioanalytical support in all aspects for one of the argenx indication franchises....
-
Regulatory Affairs Specialist
il y a 4 semaines
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...
-
junior Regulatory Affairs Specialist
il y a 3 semaines
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...
-
Associate Cmc Regulatory Scientist
il y a 1 semaine
Gent, Belgique Ardena Temps plein**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...
-
Senior Regulatory Affairs Specialist
il y a 3 semaines
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...
-
Managing Director
il y a 4 semaines
Gent, Belgique Fortior Temps plein_**Ambitieuze projectontwikkelaar zoekt een managing director met passie voor vastgoed. Word jij getriggerd door de mogelijkheid om de cockpit van de onderneming te betreden en een belangrijke rol te spelen in de verdere groei van onze organisatie? Dan is de functie van managing director bij Fortior iets voor jou!**_ **Wie zijn wij?** Fortior is een...
-
Director Analytical Development
il y a 5 jours
Gent, Belgique Ardena Temps plein**About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...
-
Communications Director Volvo Group
il y a 4 semaines
Gent, Belgique HAYS Temps pleinGent | Communications Director | Volvo Trucks | Management | Strategisch | Teamleader | Duurzaamheid | 1093250 **Jouw nieuwe functie** Als Communications Director speel jij een cruciale rol om het verhaal van Volvo Group eerlijk en overtuigend te vertellen aan de medewerkers, klanten, studenten en de samenleving. Dit op nationaal niveau. Wij zoeken een...
-
Technical Facilities Director
il y a 3 semaines
Gent, Flandre, Belgique Robert Walters Temps pleinA global leader active in the Facility Services industry is currently looking for a Technical Facilities Director to be based in Ghent region at their client's site. As Technical Facilities Director you will directly report to the Business Unit Director.In this role, some of your responsibilities will include:Holding full responsibility over the P&L...
-
Sales & Marketing Director
il y a 4 semaines
Gent, Belgique Fortior Temps plein_**Ambitieuze projectontwikkelaar zoekt een sales & marketing director met passie voor vastgoed. Word jij getriggerd door de mogelijkheid om de cockpit van de onderneming te betreden en een belangrijke rol te spelen in de verdere groei van onze organisatie? Dan is de functie van sales & marketing director bij Fortior iets voor jou!**_ **Wie zijn...
-
Regulatory Liaison Eu
il y a 4 semaines
Gent, Belgique Argenx Temps pleinThe Regulatory Affairs team is expanding and is currently looking for a Regulatory Liaison. Purpose of the position: Assists in global regulatory activities and manages the operational aspects of regulatory filings, and other to health authorities. Supports global regulatory leader(s) in execution of project strategies. Key...
-
Director Agency
il y a 1 semaine
Gent, Belgique TREVI AB Gent Temps pleinFunctieomschrijving - Met meer dan 40 jaar ervaring heeft _Trevi_ een stevige reputatie opgebouwd als marktleider in verhuur en verkoop van vastgoed in Wallonië. Trevi _onderscheidt zich met diverse specialisaties_ zoals verkoop nieuwbouw, kopen op lijfrente, een eigen architect,_ - De ambities van Trevi zijn erg groot waarbij de komende jaren _een forse...
-
Director of Sales
il y a 4 semaines
Gent, Belgique Marriott Ghent Temps plein**Job Ref**:INT18295 **Branch**:Marriott Ghent **Location**:Marriott Ghent, Belgium **Contract type**:Permanent **Hours**:Full Time **Hours per week**:38 **Posted date**:08/08/2023 **Closing date**:10/09/2023 Who are we? The Ghent Marriott, one of the leading hotels in Ghent, is managed by Aimbridge Hospitality EMEA, a division of the global...
-
Director of Corporate Finance
il y a 1 jour
Gent, Belgique Argenx Temps pleinAt argenx, we are committed to pioneering the discovery, development, and commercialization of innovative immunology therapies to transform the lives of patients worldwide. Our dynamic team operates at the forefront of biotechnology, driven by a passion for scientific excellence and a dedication to improving patient outcomes. - We are seeking a highly...
-
Head of Science Policy
il y a 1 semaine
Gent, Belgique VIB Headquarters Temps pleinVIB is an entrepreneurial non-profit research institute, with a clear focus on ground-breaking strategic basic research in life sciences and operates in close partnership with the five universities in Flanders. VIB is in search for a **leader** for its **Science Policy team**, reporting to the Managing Director. **Role purpose**: Lead the Science Policy...
-
Commercial Director
il y a 4 semaines
Gent, Belgique Lesaffre Temps pleinCompany Description Algist Bruggeman, a subsidiary of the Lesaffre Group, produces baker’s yeast for both traditional and industrial bakeries and for the private home baker. The baker's yeast is sold in fresh, liquid or dry form. In addition, Algist Bruggeman is selling improvers, mixes and premixes completed with a wide range of sourdough products. In...
-
Commercial Director
il y a 4 semaines
Gent, Belgique LESAFFRE GROUP Temps pleinDomaine d'activité- Ventes- Catégorie- Baking- Localisation- Ghent, Belgium- Type de contrat- Permanent ContractDescription de l'offre **Tasks and responsibilities** Sales - Responsible for the annual as well as strategic mid-term **Sales plan for Benelux** region. - Develop and maintain a **network with major stakeholders** inside and outside the local...
-
Global R&d Technical Director
il y a 4 semaines
Gent, Belgique Beaulieu International Group Temps plein**A passion for R&D and technology? Excited about working in an international environment alongside the most innovative minds?** **Become our R&D Technical Director for all our Cushion Vinyl plants worldwide.** **Main responsibilities and key tasks** - You will constantly strive to improve existing products, processes and procedures for all Cushion Vinyl...
-
Pharmaceutical Consultant
il y a 1 semaine
Gent, Belgique Nuwhï Temps pleinDo you want to be an expert in **medical affairs** - **market access** and **regulatory affairs**? We have a great opportunity to be able to learn and to get an expert in these fields. The great thing about it, is that this mix of RA and Medical affairs or Market access is not that common in the field. This could be the reason why you as an RA professional...