Associate Director, Global Regulatory Affairs

Vor 7 Tagen

Zürich ZH, Schweiz Takeda Pharmaceutical Vollzeit

The Regulatory Affairs-Labeling, Associate Director is responsible for ensuring that Takeda gains regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of bringing better health to people and a brighter future to the world.

**How you will contribute**:

- The Associate Director, GRA Labeling Compliance, is responsible for the strategic and operational activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs.
- Partners with internal stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas, Local Operating Companies and Supply Chain on all matters related to global labeling compliance and quality.
- With the Director of Global Labeling Compliance, is responsible for successful labeling compliance and quality management, end-to-end tracking of global labeling updates, and implementation of Global Labeling processes.
- As a member of a growing Global Labeling Compliance organization, is involved in setting the direction for the team within Takeda, identifying and attracting the best talent to the organization, and strategizing the future of the organization with the Director of Labeling Compliance and others.

**ACCOUNTABILITIES**:

- Collaborates with Global Labeling leadership to ensure clear and timely communication about labeling compliance activities and metrics.
- Responsible for alignment with global strategic initiatives related to labeling events and the processes and systems used to manage labeling compliance.
- Development and leadership of the following activities at a global level in collaboration with Head of GRA Labeling Compliance:

- Responsible for labeling compliance-relevant strategic initiative activities which may impact labeling compliance and labeling processes (labeling event management systems, RIM systems, and quality documents).
- With Global Labeling Operations, develop new and updated processes for labeling and labeling compliance, as required.
- Ensure Takeda is aligned and responsive to external guidelines and regulations as they pertain to applicable regulatory requirements, i.e., oversight of creation of PSMF Annex F tables 1 and 2.
- Provide Global Labeling Compliance support for internal and external audits:

- Ensures inspection readiness
- Coordinates Global labeling documentation requests prior to, during and in follow up to inspections/audits
- Provide support to Global Labeling SMEs on presentations related to global labeling processes for inspections and audits
- Presents on global and regional labeling processes and quality to inspectors and auditors
- Supports the development of responses and CAPAs related to global labeling for audits/inspections
- Provides regulatory and technical expertise to manage the regulatory inspection preparation and execution processes, including development of related tools and best practices
- Guide activities to provide a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits
- Ensures Labeling Commitments to partners and third parties are documented and tracked in the appropriate repository
- Escalate issues/problems to senior management as needed
- Provides input on budgets for the group as appropriate.
- Maintains strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory Affairs and labeling
- Represents Takeda at relevant Industry Forums e.g., LabelNet

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- Bachelor’s degree (or equivalent) required. Masters preferred.
- 8 plus years in pharmaceutical industry, with good exposure to Regulatory Affairs, labeling, quality assurance, and/or compliance.
- Familiarity with inspections and audit procedures
- Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Demonstrated knowledge of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Capability to critically analyze complex and/or ambiguous in

  • Associate Director

    vor 1 Woche

    Zürich, ZH, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** **Your tasks in detail**: - Provides regulatory operational support for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations. - Responsible for regulatory oversight of...

  • Head Medical und Regulatory Affairs

    Vor 6 Tagen

    Zürich, Zürich, Schweiz WILHELM AG Vollzeit

    Hoher Anteil an VerantwortungAls künftige/r Head Medical & Regulatory Affairs verantworten Sie die Bereiche Medical Affairs, Pharmakovigilanz, Regulatory Affairs, Qualitätsmanagement und nehmen die gesetzliche Vertretung bei klinischen Studien wahr. Als Mitglied der Geschäftsleitung führen Sie die einzelnen Bereiche des Medical...

  • Associate Director

    Vor 4 Tagen

    Zürich, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Client:TakedaLocation:-Job Reference:0c59a5b68dc3Job Views:11Posted:21.01.2025Expiry Date:07.03.2025Job Description:DescriptionAssociate Director - Global Medical Excellence LeadPURPOSE:Partner with Takeda business units to drive strategic and operational alignment of Medical Excellence programs that are aligned...

  • Associate Director

    Vor 4 Tagen

    Zürich, Schweiz Takeda Vollzeit

    Description Associate Director - Global Medical Excellence Lead PURPOSE: Partner with Takeda business units to drive strategic and operational alignment of Medical Excellence programs that are aligned with overall corporate goals and objectives. Ensure successful development and execution of training designed to build functional skills and...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zürich, Schweiz pharma-jobs24.ch Vollzeit

    Sie möchten Ihre Expertise gezielt in einer neuen beruflichen Herausforderung unter Beweis stellen, um Ihr Potential voll ausschöpfen zu können? Dann gehen Sie jetzt mit uns Ihren nächsten Karriereschritt!bruederlinpartner bringt als spezialisierter Personaldienstleister jeden Tag Fach- und Führungskräfte mit nationalen und internationalen Unternehmen...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zürich, Schweiz Takeda Vollzeit

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Head Medical

    vor 1 Woche

    Zürich, Schweiz WILHELM AG Vollzeit

    Fachverantwortung in tollem Familienunternehmen Unser Kunde, Dr. Falk Pharma AG, ist ein international tätiges, familiengeführtes Pharmaunternehmen mit einer langen Tradition in der Entwicklung und Vermarktung innovativer Arzneimittel. Das Unternehmen konzentriert sich auf die Bereiche Gastroenterologie und Hepatologie. In der Schweiz suchen wir einen...

  • Governmental Affairs Advisor

    Vor 6 Tagen

    Zürich, ZH, Schweiz UBS Vollzeit

    Switzerland - Zürich - Management and Business Support - Group Functions **Job Reference #** - 305028BR **City** - Zürich **Job Type** - Full Time **Your role** - Are you passionate about Swiss policy and politics? Are you a strategic mind? Do you know how to engage different stakeholders on a variety of topics? We're looking for a Governmental...

  • Head Medical

    vor 1 Woche

    Zürich, Schweiz WILHELM AG, Zürich Vollzeit

    Fachverantwortung in tollem FamilienunternehmenUnser Kunde, Dr. Falk Pharma AG, ist ein international tätiges, familiengeführtes Pharmaunternehmen mit einer langen Tradition in der Entwicklung und Vermarktung innovativer Arzneimittel. Das Unternehmen konzentriert sich auf die Bereiche Gastroenterologie und Hepatologie. In der Schweiz suchen wir einen...

  • Director of Cybersecurity

    Vor 7 Tagen

    Zürich, ZH, Schweiz PostPro Ltd Vollzeit

    **Job Summary** Our client is seeking an experienced **Director of Cybersecurity **to safeguard the company’s digital infrastructure and protect against cyber threats. This role will play a critical part in ensuring data security, regulatory compliance, and the overall risk management framework. **Key Responsibilities**: - Develop and implement...

  • Head Regulatory

    Vor 4 Tagen

    Zürich, Schweiz TN Switzerland Vollzeit

    Head Regulatory & Medical Affairs 80 – 100 %, ZürichZürich, SwitzerlandSie übernehmen die Abteilungsleitung zur regulatorischen Betreuung der Human- und Veterinär-Präparate.Ihre Aufgaben :Führung, Coaching und Weiterentwicklung des Regulatory- und Medical-TeamsAufteilung der Verantwortlichkeiten innerhalb der Abteilung RegistrierungErstellung und...

  • Director, Global Public Policy Events

    vor 1 Woche

    Schlatt (ZH), Schweiz GatedTalent - Connecting Top Executive Search Firms And Executives Vollzeit

    Purpose of the roleThe Director, Global Policy Platforms and Events is responsible for developing Global Public Policy (GPP)-wide strategies and tactical plans for engagement within key multilateral platforms, including the G7/G20, OECD and for a targeted set of annual global policy events, including World Economic Forum Annual Meeting in Davos, World Health...

  • Associate Director, Clinical Quality Compliance, Zürich

    Vor 4 Tagen

    Zürich, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Client:TakedaLocation:Cambridge, MAJob Category:OtherJob Reference:365b75b92a34Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Job Title: Associate Director, Clinical Quality ComplianceAbout the role:As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the...

  • Associate Director, Clinical Quality Compliance

    Vor 4 Tagen

    Zürich, Schweiz Takeda Vollzeit

    Description Job Title : Associate Director, Clinical Quality Compliance Location : Cambridge, MA About the role: As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge...

  • Regulatory Affairs Lead EUCAN

    Vor 4 Tagen

    Zürich, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Client:ProclinicalLocation:Job Category:OtherJob Reference:d1cfc5df1d86Job Views:5Posted:21.01.2025Expiry Date:07.03.2025Job Description:Proclinical is seeking a Regulatory Affairs Lead for the EUCAN region, focusing on gastrointestinal and inflammation areas. This hybrid role requires presence in the office five...

  • Karrierechancen: Clinical Research Associate

    Vor 7 Tagen

    Bülach, ZH, Schweiz BIOTRONIK Vollzeit

    Clinical Research Associate (m/w/d) 80-100% BIOTRONIK ist einer der weltweit führenden Hersteller kardio - und endovaskulärer Implantate und Katheter für Herzrhythmusmanagement, Elektrophysiologie und Vaskuläre Intervention. Als global tätiges Unternehmen mit Hauptsitz in Berlin bieten wir Spitzenlösungen auf dem neuesten Stand von Technologie und...

  • Regulatory Affairs Lead EUCAN

    Vor 4 Tagen

    Zürich, Schweiz Proclinical Group Vollzeit

    Procinical is seeking a Regulatory Affairs Lead for the EUCAN region, focusing on gastrointestinal and inflammation areas. This hybrid role requires presence in the office five days per month. We are looking for a proactive leader to drive regulatory strategies and ensure compliance within the dermatology and pharmaceutical sectors.Please note that to be...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Jobcloud Vollzeit

    Job DescriptionEnsure compliance with current Swiss AML standards by conducting global exposure checks of new and existing clients, identifying and mitigating financial crime risks;Process account opening requests and KYC periodic reviews in line with applicable regulatory and internal frameworks;Provide advice to client advisors on AML/CTF related...

  • Pharmaceutical Affairs

    vor 1 Woche

    Zürich, Schweiz Aspen Pharma Group Vollzeit

    Do you want to make a difference? Then join Aspen Pharma Schweiz GmbH and help shape the future! As the regional subsidiary of the international pharmaceutical company Aspen Pharmacare, headquartered in Durban, South Africa, we combine the best of both worlds: short decision-making processes, a motivated and friendly team with great individual creative...

  • Associate Director, Device and Drug-Device Combinations Strategic Sourcing Operations

    vor 1 Woche

    Zürich, Schweiz Takeda Vollzeit

    DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.How you will...