Senior Manager

Il y a 5 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 talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

ROPU MIDI is a Regional Operating Unit consisting of 7 mid-sized Operating Units: Belgium, Denor (Denmark & Norway), Finland, Greece, Portugal, Sweden, and The Netherlands. MIDI is a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.

***THE OPPORTUNITY - DO WORK THAT MATTERS**:
You are looking for a new professional challenge and you would like to participate in Regulatory Affairs to the development, marketing and maintenance of innovative biologicals products? Join us and put your skills at the service of a global Animal Health team.

This is a global role, which means that you will work closely with other countries worldwide, and more particularly in Europe and France, where travels will be regularly required. For Netherlands and Belgium, the position will be possible as a full remote contract, with occasional travels to the local BI site (Amsterdam / Lelystad for Netherlands, Bruxelles / Evergem for Belgium).

***YOUR KEY RESPONSIBILITIES**:
The job encompasses the following main roles:

- As RA Research Advisor, you define what could be the best regulatory pathway for a novel concept as well as identify potential killers to avoid late dead-end, and especially for new modalities such as novel biotechnologies.
- As RA Project Leader and RA Product Manager, you are responsible for defining regulatory strategies and requirements for initiatives requiring an expertise in regulations of respective modalities in EU and other assigned geographies, anticipating the changes of the regulation environment that could impact the project or product.
- For the Senior Expert: As Mentor, you participate to the development of the RA mentees sharing your experience and expertise, developing their critical view, taking the right decision.
- With your expertise in Biologicals/Vaccines you are responsible for all regulatory aspects from development of new products to change management of existing products in Europe and assigned geographies.
- You write, review and approve development, maintenance and supporting documents, about quality, safety and efficacy parts, from a regulatory perspective.
- You are accountable for EU procedures, from pre-submission activities, over dossier preparation to the end of the procedure working in close cooperation with the different stakeholders within Boehringer Ingelheim, and with European Medicines Agency and local authorities externally.
- You are the key point of contact for internal and external stakeholders regarding technical and procedural regulatory aspects. You monitor emerging regulatory trends and integrate new requirements into registration and approval strategies, evaluating the possible risks related to the regulatory environment, and providing strategies to manage them.

In addition, your seniority level will allow you to successfully manage the following roles:

- You act as global regulatory representative in interdisciplinary teams, and lead regulatory project teams to complete new product development with success.
- You lead cross-functional or cross-organizational topics and project teams to build and maintain global processes and relationships for regulatory affairs aspects.
- You anticipate changes in the regulatory environment and evaluate the impact on projects and existing products.
- Furthermore, you cultivate professional working relationships with regulatory authorities and represent the company’s interests in external forums such as industry associations, paving the way to influence new regulations.

***WHAT YOU SHOULD BRING TO THE TEAM **:Doctoral degree in veterinary medicine or life sciences (e.g. Pharmacy, Biotechnology, Biology) is preferred, but you can justify similar advanced background in life sciences through equivalent educational or acquired experience.

Depending on the seniority level:
Biological Development and regulatory experience
- At least 7 years of experience in Regulatory Affairs, in charge of the development of Biologicals/Vaccines, with an excellent knowledge of EU regulatory legislation and requirements for the development and maintenance of Biologicals
- Good knowledge of regulations outside of EU
- Experience with authorities and regulatory forums
- Competences in the strategic evaluation of new regulations and regulatory trends, as well as their impact on the portfolio of products or projects in development Proven successful experience with European regulatory procedur

  • Senior Account Manager

    Il y a 5 mois

    Gent, Belgique Noël Franklin Temps plein

    Ben jij de **Senior Account Manager **die gebeten is door **marketing **en op zoek is naar een nieuwe uitdagende opportuniteit? Ben jij op zoek naar een mogelijkheid waar jij strategisch in contact staat met **A-brand merken**, en helpt hun merk nog visueler te maken?** **Lees dan zeker verder om deze job in **Senior Account Manager** in **Gent **beter te...

  • Senior Manager Information Security

    Il y a 3 mois

    Gent, Belgique Cerba Research Nederland Temps plein

    **Join Our Team as a Senior Manager Information Security** The Senior Manager Information Security role manages and maintains the global information security of the company. The Senior Manager Information Security provides the necessary policies, procedures, controls, and guidelines to provide and maintain the security. This involves implementations of new...

  • Senior Key Account Manager

    Il y a 4 mois

    Gent, Belgique DSV Temps plein

    If you are a current DSV employee and interested in a position in another country, please contact your Human Resource representative to discuss the process and requirements of applying. Job Req Number: 81704 Time Type: Full Time **Senior Key Account Manager** Move forward as a Senior Key Account Manager at DSV in Ghent. **About the role** As a Senior...

  • Senior Product Manager

    Il y a 4 mois

    Gent, Belgique 4PS Temps plein

    **Wat ga je doen?**: Als Senior Productmanager heb je een belangrijke rol binnen de productontwikkeling van de 4PS producten. Je bent verantwoordelijk voor de lokalisatie van België, je geeft de richting aan die 4PS Belgium moet uitgaan en betrekt de collega’s die nodig zijn om dit te realiseren. Hiervoor kijk je vanuit verschillende invalshoeken naar de...

  • Senior Product Marketing Manager

    il y a 4 semaines

    Gent, Belgique Showpad Temps plein

    **Senior Product Marketing Manager** **Locations: Ghent (Office), London (Office)** **Note**:We work in a hybrid set-up at Showpad where we value in-person interaction and flexibility. That means we expect to see you in the office twice a week and in hub locations we come together at least once a month. **Position Overview**: The Senior Product Marketing...

  • Senior Supply Chain Management Project Manager

    Il y a 5 mois

    Gent, Belgique Mobius Temps plein

    Senior Supply Chain Management Project Manager - Are you a passionate professional to manage continuous improvement projects in operational excellence? Join us and transform organisations through supply chain management and optimisation.**Praktische informatie**: Fulltime Ghent/Brussels (hybrid) **Over ons**: Möbius begeleidt al 27 jaar een diversiteit...

  • Senior Manager Construction District

    Il y a 5 mois

    Gent, Belgique NMBS Temps plein

    Hoe maak jij mee het verschil?- Als Senior Manager Construction North ben je de drijvende kracht achter veranderingen in onze stations en gebouwen. Je bent verantwoordelijk voor het District Execution team, dat een heel aantal grote projecten uitvoert die een belangrijke impact hebben op het bedrijf. - Of het nu gaat om de renovatie of bouw van een station,...

  • Senior Product Manager

    Il y a 5 mois

    Gent, Belgique Vlerick Business School Temps plein

    **Do you have a passion for digital and education? Are you result driven & ready to explore the world of our executive programmes and their participants? Are you excited about everything digital? Do you love to interact with customers? Let’s talk!** **SENIOR PRODUCT MANAGER DIGITAL TRANSFORMATION PROGRAMMES** Vlerick Business School is a...

  • Medical Information Senior Manager

    Il y a 5 mois

    Gent, Belgique Argenx Temps plein

    The Senior Manager of Content Management will assist in the content creation efforts for the Global Medical Information function which will ensure timely and accurate responses are provided to unsolicited medical and clinical inquiries from healthcare professionals, patients, clinical sites and other healthcare organizations. This position will report to...

  • Senior Product Manager

    Il y a 5 mois

    Gent, Belgique EPAM Systems Temps plein

    Do you have a product mindset? Are you excited by innovating new products ? Are you an excellent story-teller? EPAM's Product Management team is growing! We're looking for a Senior Product Manager to support clients to solve their digital transformation challenges, and to play a dual role in helping to build EPAM Product Management Capability. 280+ of the...

  • Senior Accountant/ Finance Manager

    il y a 2 semaines

    Gent, Belgique GO Ahead Consulting Temps plein

    Met meer dan 600 medewerkers en 8 sites in België, Parijs en Londen is onze klant een van de grootste drukkerijen van Europa. Voor hun Shared Service Centre in **Gent** zijn we op zoek naar een ervaren **‘Senior Accountant/ Finance Manager’. **Als senior accountant sta je, samen met een gemotiveerd team, in voor het organiseren en superviseren van de...

  • Senior Accountant

    Il y a 5 mois

    Gent, Belgique 3W Select Interim Management Temps plein

    **Senior Accountant**: Finance Management IGhent Area I40 uur **Function description** - Manage day-to-day accounting operations and financial reporting. - Ensure accuracy and completeness of financial records and compliance with accounting standards and regulations. - Lead month-end and year-end closing processes, including preparation of financial...

  • Franchised Senior Sales and Events Manager

    Il y a 5 mois

    Gent, Belgique Marriott International, Inc Temps plein

    **Job Number** 23211323 **Job Category** Sales & Marketing **Location** Residence Inn Ghent, Akkerhage 2A, Ghent, Oost-Vlaanderen, Belgium VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** Y **Position Type** Management **Additional Information**:This hotel is owned and operated by an independent franchisee, Aimbridge...

  • Senior Account Relationship Executive

    Il y a 5 mois

    Gent, Belgique Wolters Kluwer Temps plein

    Job Summary - Within the Finance, Risk & Reporting business unit (FRR) - part of the Corporate Performance & ESG division of Wolters Kluwer - we are looking for a Senior Account Relationship Executive! - The Senior Account Relationship Executive will be responsible for selling the Wolters Kluwer OneSumX for Finance, Risk and Regulatory Reporting solutions in...

  • Senior Manager Pharma

    Il y a 5 mois

    Gent, Belgique Chronion Consulting Temps plein

    What's in the job? Advise our clients on various projects in supply chain excellence. This includes (digital) supply chain transformations, ‘sales & operations planning’ improvements, logistics and network optimization, product management, customer experience optimization, and many more... - Develop our offering and proposition for the pharmaceutical...

  • Senior Manager QA Operations

    Il y a 5 mois

    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview**: The **Senior**...

  • Senior Product Manager

    Il y a 2 mois

    Gent, Belgique Showpad Temps plein

    **Where are you based?** This role is available for Hybrid working from our **Ghent** office. **What's the mission?** Hi there! Are you a strategic thinker with a passion for driving innovation and creating impactful software solutions? At Showpad, we're looking for a **Senior Product Manager** to help us in shaping the strategic direction and roadmap for...

  • Senior Product Manager

    Il y a 7 mois

    Gent, Belgique Deliverect Temps plein

    **Deliverect** As a rapidly scaling global SaaS unicorn, Deliverect stands at the forefront of revolutionising technological solutions for the dynamic hospitality and Q-commerce sectors. Our mission is clear: to empower ambitious individuals with the skills and knowledge to make a positive impact on business. Developing in their professional careers, all...

  • Senior Commercial Manager Stadsverwarming Gent

    Il y a 2 mois

    Gent, Belgique Luminus Temps plein

    Publicatiedatum: 20 augustus 2024 - Gent - Contract onbepaalde duur De Senior Commercial Manager Stadsverwarming Gent plant, coördineert en controleert alle activiteiten die verzekeren dat alle geleverde warmte correct gevaloriseerd wordt om de rendabiliteit van de stadsverwarming Gent te waarborgen. Hij/zij verzekert tevens de nodige prospectie voor de...

  • Senior Project Manager Soil Investigation and

    Il y a 5 mois

    Gent, Belgique ENGIE Temps plein

    **Tractebel is a global engineering and consulting company delivering integrated solutions for sustainable energy and built environment projects. Our expertise is trusted worldwide across multiple markets like nuclear, renewables, power & gas, electrical grids, hydropower & dams, water resources & supply, desalination, complex & high-tech buildings,...