Associate Director, Gra Regional Compliance

Vor 2 Tagen

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as an **Associate Director, GRA Regional Compliance - ICMEA, Russia**, based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.**

**OBJECTIVES**:

- Provide direction and leadership in the identification, creation, and execution of GRA Compliance initiatives to drive overall compliance and growth, within Regional and Local Operating Companies (LOCs), while meeting Takeda corporate objectives.
- Responsible for overseeing with the regions/LOCs, updates and maintenance of systems linked to regulatory activities e.g., Regulatory Information Management System, including the timeliness, quality and accuracy of information.
- Oversees the implementation of GRA processes, systems and procedures for GxP processes (e.g. change control, deviations/CAPAs, etc.) within the region/LOC ensuring execution and compliance.
- Provides direction and oversight in the management of submissions and submission activities within the regions/Local Regulatory Affairs in accordance with local regulations
- Responsible for overseeing global regulatory compliance metrics at a country/regional level
- Oversight of audits and inspections related to Regulatory affairs processes globally within the regions/LOCs
- Partners and provides direction with the Regulatory Area Heads on key Regulatory strategic initiatives and/or issues
- Partner effectively with cross functional teams, in the proactive identification of key regulatory compliance issues to determine actionable project proposals and drives them to successful resolution

**ACCOUNTABILITIES**:

- Responsible for demonstrating Takeda leadership behaviors.
- Lead critical GRA projects for GRA Compliance for both strategic and operational organization, compliance and effective implementation
- Drives compliance within the LOCs linked to regulatory submissions including the updating and maintenance of systems used for regulatory activities
- Monitors global regulatory compliance performance within LOC RA and takes action to address issues within LOC or in GRA
- Oversees the development, implementation and understanding of regional and local RA training materials related to global regulatory processes/systems. Delivers training as needed
- Oversees the update and management of all regional/Local Information/access sites/portals/distributions; and facilitate creation, implementation and maintenance of communications and effective change management of RA processes in region/LOCs.
- Oversees inspection and audit activities within the region/LOC RA. Monitors trends and looks for opportunities to ensure audit and inspection readiness
- Develop strong partnerships with cross functional leadership within the region and LOCs.
- Lead and engage in efforts to simplify and optimize business processes and platforms to drive growth and seeks opportunities for automation of manual processes

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- Bachelor’s Degree in a science or business-related field.
- 8+ years of experience in pharmaceutical industry, with 6 years in Regulatory Affairs, research and development, quality assurance/compliance
- People management skills
- Familiarity with Regulatory systems
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
- Demonstrated knowledge of health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices in applicable regions.
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
- Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
- Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
- Excellent analytical, technical and problem-solving skills
- Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
- Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization.
- Excellent organizational skills and ability to prioritize as well as Project Management abilities.

**WHAT TAKEDA CAN OFFER YOU**

At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer st

  • Director, Cmc Regulatory Compliance

    vor 9 Monaten

    Zurich, Schweiz Takeda Vollzeit

    At 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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director,...

  • Gra Mpd Epic Associate Director

    vor 8 Monaten

    Zurich, Schweiz Takeda Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** - OBJECTIVES/_PURPOSE_ _ - Provides strategic and tactical advice to internal and external teams to achieve timely and efficient maintenance of programs, while ensuring compliance with applicable regulatory requirements - Partners with...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 6 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Global Regulatory Affairs CMC - Marketed Products in our Zurich office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an...

  • Associate Director Global Regulatory Affairs Cmc

    vor 7 Monaten

    Zurich, Schweiz Takeda Vollzeit

    Join Takeda as Associate Director, Global Regulatory Affairs CMC Established Products Inspired Collaboration (EPIC) Lead, where you are accountable for developing and executing on GRA CMC strategies for lifecycle management. You ensure global strategies are implemented across existing portfolio, while ensuring team effectiveness in a complex matrix...

  • Director - Gra Devices and Combination Products

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and has a team of engaged employees who strive for excellence in everything they do. **OBJECTIVES**: - Responsible for the development and...

  • Gra Cmc Lead for Small Molecules and Complex

    vor 7 Monaten

    Zurich, Schweiz CSL Behring Vollzeit

    CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better,...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Global Regulatory Affairs CMC - Marketed Products in our Zurich office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an...

  • Associate Director, Gcp Compliance Lead, Deviation

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **About** the role**: As the Associate Director, GCP Compliance Lead, Deviation Management, Clinical Quality Assurance, you will establish standards for excellence in GCP investigation documentation, root cause analysis, responses, CAPAs, and effectiveness checks to optimize effective and consistent performance within Research and Development, Plasma Derived...

  • Associate Director, Gcp Compliance Lead, Deviation

    vor 7 Monaten

    Zurich, Schweiz Takeda Vollzeit

    **About** the role**: As the Associate Director, GCP Compliance Lead, Deviation Management, Clinical Quality Assurance, you will establish standards for excellence in GCP investigation documentation, root cause analysis, responses, CAPAs, and effectiveness checks to optimize effective and consistent performance within Research and Development, Plasma Derived...

  • Associate Director/ Director, Eucan Regulatory

    Vor 4 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a ** Director, EUCAN Regulatory Lead, Oncology** in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** **Objective**: - Defines, develops and leads regional strategies to maximize regulatory...

  • Director of Compliance

    vor 7 Monaten

    Zurich, Schweiz RULEMATCH AG Vollzeit

    RULEMATCH has built a digital assets trading and clearing venue with world-class partners to meet the specific needs of regulated financial institutions. By offering significantly more capital-efficient and lower latency trading, RULEMATCH is helping increase institutional adoption and enable the next evolution of the crypto and digital asset market. We are...

  • Legal Associate

    vor 1 Woche

    Zurich, Schweiz MME Compliance AG Vollzeit

    Description Im Rahmen unseres kontinuierlichen Wachstums suchen wir für unsere Standorte Zürich oder Zug Verstärkung als **Legal Associate / Legal Advisor Finanzmarktrecht, GwG (80% - 100%)** **Tätigkeitsbeschreibung**: - Regulatorische Beurteilung von Geschäftsmodellen im Finanzmarkt - und Paymentbereich - Ausarbeitung von Bewilligungseingaben für...

  • Associate Director Ra Instrumentation

    Vor 6 Tagen

    Zurich, Schweiz Tecan Vollzeit

    **Join Tecan! Join the market leader!** **Work in an international and dynamic environment, share our success!** Do you want to make a significant difference in how the world is looking tomorrow and contribute to the innovation of state-of-the-art, cutting-edge technology products? Then look no further and join our Quality & Regulatory team at Männedorf,...

  • Associate Director Regulatory Affairs, Marketed

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an **Associate Director, EUCAN (Europe & Canada) Regulatory Affairs **Strategy Lead, Marketed Products **in our **Zurich** office. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: -...

  • Legal Associate Blockchain, Dlt Und Finanzmarktrecht

    vor 7 Monaten

    Zurich, Schweiz MME Compliance AG Vollzeit

    Beschreibung Die Details zum Inserat sind auf unserer Karriereseite zu finden: Legal Associate Blockchain, DLT, Finanzmarktrecht (mme.ch) Standort Standort: Straße: Stadt: - Land: Zürich oder Zug Zollstrasse 62 8005 Zürich oder Zug - SchweizZusätzliche Standorte Standort: Straße: Stadt: - Land: MME Zug Gubelstrasse 22 6300 Zug -...

  • Director of Compliance

    vor 1 Tag

    Zurich, Schweiz RULEMATCH AG Vollzeit

    RULEMATCH is a promising venture in the field of digital asset trading for institutional market participants and is looking for a Director of Compliance (f/m). Tasks - Handling of all compliance matters of the company - Responsibility for compliance with laws and regulation in the areas of financial market law and prevention of money laundering -...

  • Regional Director Medical Affairs- Mer Region

    Vor 2 Tagen

    Zurich, Schweiz MSD Vollzeit

    Join a multi-award-winning leading biopharmaceutical company Be part of best-in-class Medical Affairs Team Your chance to be at the center of innovation and excellence in execution. The Regional Director of Medical Affairs (RDMA) for Women’s Cancer holds primary responsibility for developing and executing Oncology Global Medical Affairs strategies in...

  • Associate Director Integrated Marketing

    vor 7 Monaten

    Zurich, Schweiz Tecan Trading AG Vollzeit

    Tecan Trading AG Ever wondered how your skills and unique background could impact the world of tomorrow? Join our Global Marketing team and bring your passion and talent to work. Associate Director Integrated Marketing Männedorf, Switzerland Your contribution Responsibilities will include Develop a global strategic marketing plan in collaboration with...

  • Associate Director Integrated Marketing

    vor 7 Monaten

    Zurich, Schweiz Tecan Trading AG Vollzeit

    Tecan Trading AG Ever wondered how your skills and unique background could impact the world of tomorrow? Join our Global Marketing team and bring your passion and talent to work. Associate Director Integrated Marketing Männedorf, Switzerland **Your contribution** Responsibilities will include - Develop a global strategic marketing plan in collaboration...

  • Associate Business Risk Account Openings Uhnwi/hnwi

    Vor 2 Tagen

    Zurich, Schweiz coni+partner AG Vollzeit

    Our client is a bank in Zurich. We are looking for a compliance specialist (m, f, d) as a Associate Business Risk Account Openings UHNWI/HNWI Aufgaben Qualifikation Professional experience in Private Banking, Trust or a Family Office or Compliance Consulting (BigFour) / Knowledge of client identification processes and regulations in the area of...