Aktuelle Jobs im Zusammenhang mit Associate Director, Global Regulatory Affairs CMC - Zürich, Zürich - Takeda Pharmaceuticals International AG

  • Regulatory Affairs Manager

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryTakeda is seeking a highly skilled and experienced Associate Director to lead our Device and Drug-Device Combinations Strategic Sourcing Operations team. As a key member of our Global Regulatory Affairs CMC Device and Drug-Device Combinations team, you will be responsible for end-to-end management of device and drug-device combination work...

  • Regulatory Affairs Specialist

    Vor 2 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking an experienced Associate Director to lead our Device and Drug-Device Combinations EU and Global Markets team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing innovative regulatory strategies for our combination product portfolio.Key ResponsibilitiesDevelop and implement...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Takeda. As a key member of our Global Regulatory Affairs CMC Device and Drug-Device Combinations team, you will be responsible for end-to-end management of device and drug-device combination work outsourced to external partners.Key ResponsibilitiesUtilize regulatory...

  • Regulatory Affairs Director for Precision Medicine and Digital Health

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to lead our precision medicine and digital health efforts. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies for biomarkers, diagnostic tests, and digital health tools.Key ResponsibilitiesProvide strategic and tactical advice...

  • Regulatory Affairs Director for Precision Medicine and Digital Health

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job DescriptionJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to lead our precision medicine and digital health efforts. The successful candidate will be responsible for developing and implementing global regulatory strategies for biomarkers, diagnostic tests, and digital health tools.Key ResponsibilitiesProvide strategic and tactical...

  • Regulatory Affairs Specialist

    Vor 7 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Takeda. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for clinical trials in the EUCAN and GEM regions.Key ResponsibilitiesDevelop and implement operational plans for clinical trial...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Amaris Consulting Vollzeit

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amaris Consulting. As a key member of our client's team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the smooth operation of our client's business.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Zürich, Zürich, Schweiz Amaris Consulting Vollzeit

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amaris Consulting. As a key member of our client's organization, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful launch of products.Key ResponsibilitiesRegulatory Compliance: Ensure that all products...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Amaris Consulting Vollzeit

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amaris Consulting. As a key member of our client's organization, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful launch of products.Key ResponsibilitiesRegulatory Compliance: Ensure that all products...

  • Compliance Operations Lead, Associate Director

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking a highly skilled Compliance Operations Lead, Associate Director to join our team at Takeda. This role will be responsible for ensuring the effective implementation of Global and R&D Quality processes across CPMQ, as well as partnering with teams to assess needs for functional processes and system enhancements.Key...

  • Compliance Operations Lead, Associate Director

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking a highly skilled Compliance Operations Lead, Associate Director to join our team at Takeda. This role will be responsible for ensuring the effective implementation of Global and R&D Quality processes across CPMQ.Key ResponsibilitiesPartner with teams across CPMQ to assess needs for functional processes and system enhancements.Lead...

  • Compliance Operations Lead, Associate Director

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryTakeda is seeking a highly skilled Compliance Operations Lead, Associate Director to join our team. This role will be responsible for ensuring Global and R&D Quality processes are embedded and effectively implemented across CPMQ.Key ResponsibilitiesPartner with teams across CPMQ to proactively assess the needs for functional processes and system...

  • Regulatory Affairs Professional

    vor 2 Wochen

    Zürich, Zürich, Schweiz Amaris Consulting Vollzeit

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amaris Consulting. As a key member of our client's organization, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the development and submission of regulatory documents.Key ResponsibilitiesRegulatory Compliance:...

  • Associate Director, Tech Transfer Leader

    vor 2 Wochen

    Zürich, Zürich, Schweiz Merck Sharp & Dohme (MSD) Vollzeit

    Job SummaryWe are seeking a highly motivated individual to lead our Large Molecule Technology Transfer team as an Associate Director. This role will be responsible for overseeing the end-to-end technical transfer leadership for technology transfers to all large molecules in pipeline and inline space.Key ResponsibilitiesManage and lead collaboration for TT...

  • Regulatory Affairs Counsel

    vor 2 Wochen

    Zürich, Zürich, Schweiz Axiom Vollzeit

    **About the Role**We are seeking a highly skilled Healthcare/Pharma Legal Expert to join our team at Axiom. As a key member of our legal team, you will work closely with clients across various industries to provide expert legal advice and support.Key Responsibilities:Develop and implement effective legal strategies to support business growth and expansion in...

  • Associate Director, Clinical Quality Compliance Specialist

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    About the Role:We are seeking an experienced Associate Director, Clinical Quality Compliance to join our team at Takeda. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management,...

  • Regulatory Therapeutic Area Team Lead

    Vor 7 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Therapeutic Area Team Lead to join our EUCAN team. As a key member of our regulatory affairs team, you will be responsible for overseeing and directing all regulatory activities related to oncology products.Key ResponsibilitiesProvide strategic leadership and oversight to a team of...

  • Regulatory Expert for Drug-Device Combinations

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Expert to join our team at Takeda, a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a key member of our regulatory team, you will play a critical role in shaping our global regulatory strategies and ensuring compliance with EU and Global...

  • Regulatory Risk Management Specialist

    vor 23 Stunden

    Zürich, Zürich, Schweiz Q-Perior Vollzeit

    Unlock Your Potential with Q-PeriorWe're a leading consulting firm driving strategic transformations. As a trusted partner for our clients and employees, we empower you to achieve your personal vision.Our dynamic environment fosters growth, with a focus on employee development and a variety of opportunities to advance your passions.Join us in shaping the...

  • Global Regulatory Policy and Innovation Leader

    vor 2 Wochen

    Zürich, Zürich, Schweiz Takeda Vollzeit

    About the RoleWe are seeking a highly experienced and skilled professional to lead our Global Regulatory Policy and Innovation team. As the International Head, Global Regulatory Policy and Innovation, you will be responsible for developing and implementing global regulatory strategies to support the company's business objectives.Key...

Associate Director, Global Regulatory Affairs CMC

vor 4 Monaten

Zürich, Zürich, Schweiz Takeda Pharmaceuticals International AG 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 Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

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 working on the Global Regulatory Affairs CMC team, you will be responsible and accountable for regulatory CMC development, registration and post-approval strategies, and a typical day will include:

Objective / Purpose

  • With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
  • Has a strong and deep foundational understanding of global RA CMC regulations and guidelines. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.
  • Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.

Accountabilities

  • With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy
  • Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
  • With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters.
  • Interacts directly with international Health Authorities on administrative procedural topics, as required.
  • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
  • Fosters constructive working relationships when interacting with internal and/or external colleagues.
  • Evaluates change proposals for global regulatory impact.
  • As a GRA CMC member, ensures and/or enhances regulatory compliance.
  • If in a line manager role, provides project and administrative oversight, mentorship and guidance to direct reports, develops talent, fosters DEI principles and ensures open communication.

Education & Competencies (Technical and Behavioral)

  • BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
  • 10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered).
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
  • Analyze issues with attention to detail.
  • Ability to assess alternative approaches.
  • Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
  • Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
  • Understands who is responsible for different decisions and escalates as necessary
  • Applies decisions taken by the company
  • Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
  • Intentionally promotes an inclusive culture
  • Applies the given prioritization framework with limited support
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
  • Excellent written and oral communication skills required.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool

Learn more at

LocationsZurich, Switzerland
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time