Manager, Regulatory Submissions Publishing

vor 1 Woche

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 **Manager, Regulatory Submissions Publishing** to be based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.**

**OBJECTIVES**:
**ACCOUNTABILITIES**:

- Plans and manages detailed publishing timelines; provides reporting on publishing status to key stakeholders.
- Proactively escalates publishing concerns, risks and issues that may delay/impact the submission and presents risk mitigation for publishing strategy.
- Collaborates with other functional managers to develop strategies to mitigate risks to timelines and other issues
- Keeps abreast of fluency with regulatory agency submission, publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
- When necessary and appropriate, steps in for or lends assistance to individual contributor direct reports to help drive results and achieve objectives.
- Work closely with content providers to produce high quality submission-ready documents that adhere to internal and external electronic submission guidelines
- Ensure submission documents meet the level of technical integrity required for Takeda publishing tools
- Provide authors with formatting assistance as needed, as well as guidance with regards to publishing and referencing processes
- Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of submissions
- Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies
- Assist with the development of publishing processes and/or documentation as needed, including user acceptance testing for new or updated publishing tools

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- 6 + years of experience in pharmaceutical/biotech industry, with 4+ years of hands-on global regulatory submissions management and publishing experience.
- Bachelor of Science Degree in Technical Discipline such as Life Sciences or Health Care Professions (Engineering, Biology, Chemistry, Nursing, Pharmacy) or related discipline; Advanced degree preferred.
- Fully understands regulatory publishing and electronic document management systems
- Master knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
- Significant experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
- Experience with supporting and leading successful delivery of projects (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change / transformation projects
- Understanding of relationship management with demonstrated experience in partnering in large scale situations
- Business analytics experience and innovative thinking in order to drive insights into operations and change management and support strategic sourcing decisions.
- Expert at motivating individuals and teams to manage the change aspects of implementing a new, outsourced model.
- Must have proven track record to be able to think critically, strategically, independently and problem solve
- Must have high level of motivation, drive, and demonstration of Takeda’s leadership values
- Excellent written and verbal communication skills
- Top notch interpersonal skills in difficult situations
- Ability to work seamlessly with all levels of personnel
- Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations

**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 stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future _**to people around the world.

**Empowering Our People to Shine**

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

  • Associate Director, Regulatory Publishing and

    vor 1 Tag

    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 **Associate Director, Regulatory Publishing and Submission Management**. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVES/PURPOSE**:_ _ This key position is part of Global Regulatory Operation...

  • Director, Publishing and Submission Management

    vor 1 Woche

    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, Publishing and Submission Management** to be based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVES**: This key position is part of Global Regulatory Operation (GRO) and...

  • Manager Regulatory Affairs

    Vor 4 Tagen

    Zurich, Schweiz Experis Vollzeit

    **Manager Regulatory Affairs** Experis IT is on the search for a **Manager Regulatory Affairs** to join one of their clients, a well-known international pharma company based in Switzerland. **Contact**:Francesca De Chirico **Start Date: ASAP** **Duration**:12** **M**onths** **Location**:Zürich** **Workload percentage**:100%** **Hybrid Model** **Key...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Zurich, Schweiz Pfizer Vollzeit

    **Regulatory Affairs Manager (M/F)** **Contract limited** **This is what you can look forward to**: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. -...

  • Regulatory Affairs Manager

    Vor 3 Tagen

    Zurich, Schweiz NonStop Consulting Vollzeit

    Regulatory Affairs Manager role - Switzerland (German) - CMC I am currently looking for an experienced Regulatory affairs manager, CMC to join a good reputation employer in a German canton of Switzerland. In your role you will be responsible for all CMC aspects, providing strategic and operational guidance to different teams in order to ensure achieving the...

  • Manager, Clinical Trial Regulatory Lead

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** - Objective / Purpose_:_ _ - Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy...

  • Eucan Regulatory Manager

    vor 2 Wochen

    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 **EUCAN Regulatory Manager - Clinical Trials** in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** Under supervision from a senior team member and/or in collaboration with EUCAN Regulatory Lead: -...

  • Sr. Manager, Eu Regulatory Lead

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **OBJECTIVE**: - Collaborates to define, develop and sometimes lead regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives - Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining...

  • Director, Eucan Regulatory Affairs Lead

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** **OBJECTIVE**: - Effectively communicates the regulatory strategies, submission plans and timelines; assessment of the likelihood of success of the regulatory strategies and impact assessments of trends, regulations and changes related to...

  • 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,...

  • Eucan Regulatory Affairs Manager, Oncology

    vor 2 Wochen

    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 **EUCAN Regulatory Affairs Manager, Oncology,** based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Provides regional strategic and tactical advice and guidance to teams to...

  • Regulatory Affairs Manager

    vor 7 Monaten

    Zurich, Schweiz Sonova Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Regulatory Manager

    vor 7 Monaten

    Zurich, Schweiz FE fundinfo Vollzeit

    FE fundinfo is a global leader in investment fund data and technology and we are currently recruiting for a Regulatory Manager to join our team in Zurich (hybrid working). As a Regulatory Manager, you are tasked with driving the offerings the company has as a result of new or existing regulations. You will hold a fundamental position with key influence to...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Zurich, Schweiz Hays Vollzeit

    **My duties** - Ensures regional regulatory strategies are written, reviewed and executed according to plan - In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements - Manages, plans, and...

  • Regulatory Affairs Cmc Manager

    Vor 3 Tagen

    Zurich, Schweiz CSL Behring Vollzeit

    CSL Vifor is a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company. We are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. - Effectively collaborate with technical experts, oversee and direct compilation and update of CMC related dossier components,...

  • Ra Manager

    vor 1 Woche

    Zurich, Schweiz BioTalent Vollzeit

    BioTalent are partnered with an exciting company to assist their search for a newly created Regulatory Affairs Manager on a permanent basis as part of their ongoing growth plans. **Key Responsibilities**: - Maintain the approved dossiers of the lifecycle of the products - Ensure that Regulatory procedures and records with respect to CMC / Quality are in...

  • Director Global Regulatory Affairs, Rare Genetics

    vor 2 Wochen

    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 Global Regulatory Affairs, Rare Genetics and Hematology - Gene Therapy** to be based in, based in either Zurich, Switzerland or Cambridge, Massachusetts, USA. **Here, you will be a vital contributor to our inspiring, bold...

  • Manager Corporate Publishing

    vor 7 Monaten

    Zurich, Schweiz communicationnetwork.ch Vollzeit

    Aufgaben - Recherchieren von Magazinbeiträgen, Planung und Umsetzung in multimedialen Onlineformaten - Konzeption, Planung, Distribution und Evaluation von Geschäftsberichten, Webseiten und weiteren crossmedialen Publishing-Formaten - Beratung von Produktsegmenten und Fachabteilungen in Sachen Content Marketing - Leitung von Projekten zur Weiterentwicklung...

  • Director, Global Regulatory Affairs Cmc

    Vor 6 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Join Takeda as a Director, Global Regulatory Affairs (GRA) CMC, where you will lead GRA CMC Due Diligence in partnership with organizational and external stakeholders. You will ensure the communication/development of regulatory CMC risks and strategy, develop best practices that enable CMC due diligence, ensuring that a given compound meets technical and...

  • Manager Regulatory Reporting

    vor 7 Monaten

    Zurich, Schweiz coni+partner AG Vollzeit

    Our client is an international bank in Zurich. We are looking for an accounting specialist in fund business (m, f, d) as a Manager Regulatory Reporting Tasks Contribute to regulatory investment reportings for investors and authorities / Responsible for controlling transaction risks (minimization), transparency (SFDR), data quality and fast access to data...