Head of Team Regional Regulatory Leads

vor 2 Wochen

Straße, Deutschland BI International GmbH Vollzeit

**The Position**:
You will lead and manage a team of Regional Regulatory Leads (RRL) for EUCAN Region.

***Tasks & responsibilities**:

- In your new role, you will lead and manage a Team of Regional Regulatory Leads responsible for steering and coordination of regional regulatory activities for the EUCAN region required for development, maintenance, and expansion of world-wide marketing authorizations for the assigned BI’s global human pharma portfolio.
- With your expertise, you will ensure the delivery and execution of robust regional regulatory strategies for the EUCAN region, while ensuring our regulatory compliance.
- You will monitor and enhance the functional and personal development of the team members to drive the team goals.
- Furthermore, you will provide support to the Head of RA in establishing objectives, strategies, and priorities for the complete EUCAN team under consideration of the overall objectives.
- You will also lead assigned development projects as well as general projects, while additionally contributing to our common standards and procedures within the group.

**Requirements**:

- Doctoral Degree (e.g. PhD, MD) and/or Master’s Degree in pharmacy or life sciences. Further degrees, e.g., Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated
- Long-term experience in the pharmaceutical industry in Regulatory Affairs, and ideally also in functions outside Regulatory Affairs (e.g. research and development)
- Several years of practical experience in development projects in Oncology in the EUCAN region, with a special focus on the EU regulatory strategy
- Experience with direct Health Authority interactions (e.g. EMA/BfArM) and in handling new developments, registrations and maintenance of products
- Proven experience in successful leadership of international and cross functional project teams
- Ability to collaboratively work cross-functionally in
- and outside of the regulatory affairs organization with a good understanding of different cultures and their impact
- Fluent English skills, both written and spoken

***Ready to contact us?**:
Recruitment process:
Step 2: Virtual meeting in the period from beginning till mid of March
Step 3: On-site interviews mid of March

  • Team Lead Regulatory CMC Writing

    Vor 7 Tagen

    Alfred-Wegener-Straße , Frankfurt am Main, Deutschland Merz Therapeutics Vollzeit 80.000 € - 120.000 € pro Jahr

    YOUR CONTRIBUTIONAs a Team Lead Regulatory CMC Writing (m/f/d), you will be the central contact point for our manufacturing site for development and maintenance of regulatory documentation to support creation of actual regulatory dossiers. This will include the following activities:Preparation of CMC documentation in compliance with internal requirements...

  • Global Head of Pricing

    vor 1 Tag

    Straße, Deutschland BI Vetmedica GmbH Vollzeit

    **The Position**: In the role as Global Head of Pricing you will shape and drive the global pricing strategy for Animal Health, ensuring optimal pricing models and strategies are in place. You will also drive the change management and innovation of the global pricing capabilities, fostering a culture of continuous improvement and innovation. Moreover, you...

  • Head of Medical Affairs Pipeline Obesity

    vor 1 Tag

    Straße, Deutschland BI International GmbH Vollzeit

    **The Position**: Are you ready to shape the future of medical innovation in one of the most dynamic therapeutic areas? As the Head of Pipeline Medical Affairs, you will play a pivotal role in driving the vision and strategy for a distinct group of assets and indications within the newly formed Therapeutic Area Obesity & Liver Health (TA OL). Reporting...

  • Head of Development Established Dosage Forms

    vor 1 Woche

    Straße, Deutschland BI Vetmedica GmbH Vollzeit

    **The Position**: We are looking for a dynamic and experienced professional to take on the role as Head Development Established Dosage Forms in our esteemed pharmaceutical company. In this position, you will have the opportunity to showcase your leadership skills, set new standards, and contribute to the advancement of cutting-edge pharmaceutical development...

  • Head Development Innovative Dosage Forms

    Vor 3 Tagen

    Straße, Deutschland BI Vetmedica GmbH Vollzeit

    **The Position**: ***Tasks & responsibilities**: - Additionally, you will ensure compliance with defined Quality Target Product Profile (QTPP) and global regulatory requirements. - Evaluating and implementing new and innovative formulation/packaging concepts, as well as new technologies for manufacturing and control will also take place in your...

  • Head of

    Vor 7 Tagen

    Grünberger Straße a, Berlin, Deutschland mc-quadrat Vollzeit 80.000 € - 120.000 € pro Jahr

    Head of / Teamlead Brand & Communication Consulting  (m/w/d) für unser 4-köpfiges Consulting-Team (Vollzeit)Als Head of Consulting bei mc-quadrat lenkst Du nicht nur ein starkes Team zu Bestleistungen und berätst als Lead-Consultant bei einzelnen Beratungsprojekten unsere Kunden, sondern Du entwickelst unser Beratungsportfolio auch strategisch...

  • Medical Affairs Lead

    vor 1 Woche

    Straße, Deutschland BI International GmbH Vollzeit

    **The Position** Lead the Future of Medical Affairs for the Most Important Cardio-Renal-Metabolic Asset Are you ready to take on a transformative leadership role at the forefront of the Cardio-Renal-Metabolic space? We are seeking a visionary leader to guide the medical affairs strategy for Jardiance, the most important asset in the industry today and into...

  • Regulatory Affairs Manager

    vor 24 Stunden

    Alfred-Wegener-Straße , Frankfurt am Main, Deutschland Merz Therapeutics Vollzeit 60.000 € - 120.000 € pro Jahr

    YOUR CONTRIBUTIONAs a Regulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. The position is limited to 3 years and includes the following activities:Create, review, and update high-quality CMC documentation to obtain and maintain product...

  • Global Head of Market Channel Excellence

    vor 1 Woche

    Straße, Deutschland BI Vetmedica GmbH Vollzeit

    **The Position**: Are you a visionary with an aptitude for strategic thinking, a drive for perfection, and a deep-seated understanding of multifaceted market channels? We are looking for a dynamic, seasoned professional to step into the role of Global Head of Channel Excellence (GHCE). This isn't just a job - it's a chance to shape the future of our global...

  • Head of Department

    vor 23 Stunden

    Jürgen-Töpfer-Straße , Hamburg, HH, Germany Ramboll Vollzeit 104.000 € - 130.878 € pro Jahr

    Stellenbeschreibung Hamburg, Frankfurt am Main, Berlin, Essen, Kassel, München, GermanyWe invite you to bring your energy and experience into play as you build our German Environmental Impact Assessment (EIA) team with the support of our strong international EIA network to deliver full EIA and consenting services in combination with our wider established...