Director Regulatory Affairs

vor 2 Monaten

München, Deutschland Gilead Sciences Vollzeit

For Current Gilead Employees and Contractors:
Please log onto your

Internal Career Site

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

**Job Description**:
Director Regulatory Affairs (M/F/d)

In our German affiliate we have an opening for a leadership role within our local Regulatory Affairs team. The Director Regulatory Affairs (M/F/d) leads a team and reports to the Senior Director Regulatory Affairs, country head Regulatory Affairs. The position is office based on-site in Martinsried, Munich and requires fluent German language skills.

Detailed description:

- Ensures compliant labelling for Gilead medicinal products and manage timely updates for assigned product(s)
- Lead or support country/national scientific advice and / or pre-submission meeting preparation and follow-up
- Provides strategic regulatory advice as appropriate including input into clinical development programmes
- Support for communicating important changes to the local Regulatory and RSQ function/activities acting as a consultant to local Affiliate, regional, Intl or Global RA teams
- Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility
- Provides or contributes to the Vision and Direction for the RA organization at the country level in line with global/Regional RA and local Affiliate Visions and sets clear goals and objectives in line with the global RSQ strategy
- Support or management of quality defects, falsified or counterfeit products, batch recalls and stock out as required
- Responsible for the review of promotional and non-promotional material and approval, certifies materials where appropriate for assigned product(s)
- Might act as a local Gilead representative as required by local law e.g. Qualified Person QA, QPPV, Responsible Person PV, RP QA, National qualified person for scientific service (Informationsbeauftragter)
- Serve as a core Regulatory member in updating and preparing the Company for major changes in regulatory legislation and competitor information in the country for assigned product(s) or projects and contributes to guideline and regulation development Represents Regulatory Function at internal and external meetings or working parties building recognition as a thought leader
- Lead or manage work in additional countries e.g. distributor markets as required
- Training or coaching of staff on key regulatory activities and updates.

General Responsibilities:

- Ensures that Gilead complies with country’s applicable legislations and regulations linked to the Marketing Authorization (MA) / local license as MA Holder or as local legal representative of the MA Holder
- Ensures that the medicinal products in her responsibility can be developed, authorized and maintained on the market
- Serves as a core member or may lead cross functional project teams locally and regionally. May also serve as a core member in global cross-functional teams.
- Senior represenstative of the Regulatory function and RSQ at internal and external meetings
- Manages a team of Regulatory professionals for assigned BU(s)/product(s)
- As the responsible person (RP) for scientific information acc to section 74a of the German Drug law (AMG) (“Informationsbeauftragte”) ensure compliance with all regulations applicable to this position, e.g. HWG, AMG, FSA Kodex.

Requested knowledge for this position:
Professional Training:
University degree preferably in Natural Sciences or Pharmacy

Experience:
Solid experience in RA or other relevant industry experience
- Special_ knowledge:_
- Excellent knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements regional and local requirements and an understanding of current trends in the local

  • Werkstudent Im Bereich Regulatory Affairs

    vor 4 Wochen

    Garching bei München, Deutschland Edwards Lifesciences Vollzeit

    **Starte deine Karriere im **Regulatory Affairs** bei Edwards Lifesciences!** **Du bist Student und suchst nach spannenden Herausforderungen in einem flexiblen Umfeld?** Dann bist du bei uns genau richtig! Wir suchen einen **Werkstudenten (m/w/d) in Regulatory Affairs **an unserem Standort in Garching bei München. **Was erwartet Dich?** - ** Mitwirkung...

  • Global Regulatory Affairs Lead

    vor 2 Wochen

    München, Deutschland Sobi Vollzeit

    Full-time Sobi Location: Switzerland **Company Description**: At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here...

  • Director Medical Affairs

    vor 2 Monaten

    München, Deutschland Regeneron Pharmaceuticals Inc. Vollzeit

    Our team of expert medical affairs physicians and scientists at Regeneron bridge the gap between our innovative medicines and the scientific and healthcare community. As the Director Medical Affairs Hematology, you will represent Regeneron in Medical Affairs and Clinical Development providing scientific and medical leadership for our Hematology assets. In...

  • Werkstudent in

    vor 2 Monaten

    80331 München, Deutschland Kranus Health GmbH Vollzeit

    **DEINE VERANTWORTUNG**: **Werkstudierendentätigkeit gesucht?** Als wachsendes Scaleup sind wir immer auch auf der Suche nach talentierter Unterstützung. Du möchtest während deines Studiums bei uns als Werkstudent:in oder Praktikant:in im Bereich Regulatory Affairs Praxiserfahrung sammeln und hast Lust auf abwechslungsreiche Herausforderungen? Dann...

  • Trainee (W/m/d) Regulatory Affairs Management

    vor 3 Monaten

    81675 München, Deutschland Denk Pharma GmbH & Co. KG Vollzeit

    **Das macht die Denk Pharma**: Seit 1948 ist die DENK PHARMA als Familienunternehmen in mehr als 80 Ländern tätig. Unter unserem Slogan "Quality for your Health - Made in Germany" schaffen wir für alle Kunden mit unseren Produkten Zugang zur Heilung. Als eines der wenigen Pharmaunternehmen weltweit erhalten alle unsere Kunden genau die gleichen Arznei -...

  • Head of Regulatory Affairs

    vor 3 Wochen

    München, Deutschland yfood Labs GmbH Vollzeit

    DEINE MISSION - Entwicklung von Zulassungsstrategien für globale Märkte, mit Schwerpunkt auf Europa - Entwicklung und kontinuierliche Verbesserung der internen Prozesse - Berücksichtigung und Umsetzung der nationalen und internationalen Richtlinien im Lebensmittelsektor durch kontinuierliche Überwachung der aktuellen gesetzlichen Regulierungen - Leitung,...

  • Director Medical Affairs

    vor 1 Monat

    München, Deutschland MSD Vollzeit

    An exciting opportunity has arisen for a **Director Medical Affairs General & Specialty Medicine **(all genders). Reporting directly to the Country Medical Director (CMD), you will be responsible for developing and implementing the Global Medical & Scientific Affairs strategy for your Therapeutic Area (TA) in line with global, regional and local...

  • Country Medical Director

    vor 1 Monat

    80339 München, Deutschland GSK Vollzeit

    **Site Name**: Munich - Office **Posted Date**: Nov 14 2024 **Country Medical Director (Senior Director) for Germany and Switzerland**: **The deadline for the job posting is the 28th of November in 2024**: **Overview**: ViiV Healthcare is a global specialist HIV company dedicated to delivering innovative new options for the care and treatment of people...

  • Director Corporate Communications Europe

    vor 4 Monaten

    München, Deutschland Regeneron Vollzeit

    Based in Munich, Germany, the Director of Corporate Communications for Europe and Canada will work in close collaboration with the Corporate Affairs team to shape the Company’s external-facing presence and reputation in key international markets. You will build relationships with country leadership in order to develop and execute communication strategies...

  • Head of Regulatory Affairs

    vor 3 Wochen

    80336 München, Deutschland yfood Labs GmbH Vollzeit

    **DEINE MISSION**: - Entwicklung von Zulassungsstrategien für globale Märkte, mit Schwerpunkt auf Europa - Entwicklung und kontinuierliche Verbesserung der internen Prozesse - Berücksichtigung und Umsetzung der nationalen und internationalen Richtlinien im Lebensmittelsektor durch kontinuierliche Überwachung der aktuellen gesetzlichen Regulierungen -...

  • Spezialist Regulatory Affairs

    vor 3 Monaten

    Garching bei München, Deutschland Münchener Hypothekenbank eG Vollzeit

    **Eigenständig - Individuell - Genossenschaftlich** Die Bankenaufsicht in Europa setzt sich aus den nationalen Aufsichtsbehörden und der Europäischen Zentralbank (EZB) zusammen. Für die Aufsicht der Münchener Hypothekenbank als bedeutendes Einzelinstitut ist die EZB direkt zuständig. Sie übernehmen gemeinsam im Team das Reporting an die...

  • Regulatory Operations Associate

    vor 2 Wochen

    München, Deutschland Daiichi Sankyo Europe Vollzeit

    Under supervision, provide regulatory operational support for European submission projects for prospective and authorize products in a timely manner. Ensure regulatory operations compliance and may act as a technical specialist in a particular area. In this role, you will be part of a highly competent team resided in Munich and in Basking Ridge/US. **Roles...

  • Intern Regulatory Affairs Germany

    vor 3 Monaten

    München, Deutschland HypoVereinsbank - UniCredit Vollzeit

    Join our diverse and multi-disciplinary Regulatory Affairs team in Germany for a deep dive into the world of managing the relationship with the banking supervisory authorities. Be part of our global network and profit from an extensive range of areas in practical banking supervision where you can contribute: Coordination of supervisory requests and surveys,...

  • Head of

    vor 3 Monaten

    81675 München, Deutschland Denk Pharma GmbH & Co. KG Vollzeit

    **Das macht die Denk Pharma**: Seit 1948 ist die **DENK PHARMA **als Familienunternehmen in mehr als 80 Ländern tätig. Unter unserem Slogan "Quality for your Health - Made in Germany" schaffen wir für alle Kunden mit unseren Produkten Zugang zur Heilung. Als eines der wenigen Pharmaunternehmen weltweit stellen wir unseren Kunden exakt die gleichen...

  • Senior Director, Global Medical Asset Lead Oncology

    vor 3 Monaten

    81677 München, Deutschland Ipsen Pharma GmbH Vollzeit

    **Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?** Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for...

  • Trainee Regulatory Affairs Germany

    vor 2 Monaten

    München, Deutschland HypoVereinsbank - UniCredit Vollzeit

    Das „**UniCredit Graduate Program**“ ist Dein Start in eine spannende und abwechslungsreiche Karriere in einem der führenden Finanzinstitute Europas. - In Deinem **12- bis 15-monatigen rotationsbasierten Traineeprogramm** lernst Du das Unternehmen ganzheitlich kennen. Du arbeitest in einem zukunftsorientierten und internationalen Umfeld, in dem Du...

  • Vice President, Regulatory and Quality

    vor 1 Monat

    München, Deutschland Veranex, Inc. Vollzeit

    Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes. **About This Role**: We are seeking an experienced Vice President of Regulatory &...

  • Senior Vice President, Regulatory and Quality

    vor 2 Wochen

    München, Deutschland Veranex, Inc. Vollzeit

    Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes. **About This Role**: We are seeking an experienced Vice President or Senior Vice...

  • Director, Evidence Generation, Statistical

    vor 3 Monaten

    81379 München, Deutschland Daiichi Sankyo Europe Vollzeit

    The Director, Evidence Generation, Statistical Innovation will be focused on enhancing statistical methodology of Biostatistics for Medical Affairs (MA), Health Economics and Outcome Research (HEOR) and Health Technology Assessment (HTA) activities. - The incumbent will be responsible to drive statistical innovation and develop efficient study design and...

  • Academic Director Canadian Degrees

    vor 4 Monaten

    München, Deutschland IU Internationale Hochschule Vollzeit

    This is a unique opportunity for an extraordinary personality: You will be part of our post-merger integration team at IU Group, fostering the program expansion at our Canadian university, leveraging the Germany-based team assisting with Canadian regulatory affairs. Specifically, you will ensure that our degree programs fit the Canadian market and are...