Associate Director, Global Regulatory Affairs CMC

vor 1 Woche

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

  • Associate Director, Global Regulatory Affairs Cmc

    vor 1 Woche

    Zürich, Zürich, Schweiz ARIAD Vollzeit

    Job Type:Full TimeJob Level:SeniorTravel:Minimal (if any)Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.At Takeda, we strive to provide transformational opportunities for...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 1 Woche

    Zürich, Zürich, Schweiz ARIAD Vollzeit

    Job Type:Full TimeJob Level:SeniorTravel:Minimal (if any)Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.At Takeda, we strive to provide transformational opportunities for...

  • Associate Director, Global Regulatory Affairs CMC

    vor 1 Woche

    Zürich, Zürich, Schweiz Takeda Vollzeit

    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...

  • Associate Director, Global Regulatory Affairs CMC

    vor 1 Woche

    Zürich, 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...

  • Associate Director Global Regulatory Affairs Cmc

    vor 1 Woche

    Zürich, Zürich, 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, Global Regulatory Affairs Cmc

    vor 1 Woche

    Zürich, Zürich, 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...

  • Director, Global Regulatory Affairs Cmc Alliance

    vor 1 Woche

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Join Takeda as Director, Global Regulatory Affairs CMC Alliance Partnered and Divested Product 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 environment. Reporting to the...

  • Director, Cmc Regulatory Compliance

    vor 1 Woche

    Zürich, Zürich, 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, CMC...

  • Director, GRA CMC Small Molecules

    vor 4 Wochen

    Zürich, Zürich, Schweiz Takeda Pharmaceuticals International AG Vollzeit

    Job DescriptionJoin our team and make a difference!Are you ready to take on a new challenge in the pharmaceutical industry? Takeda is looking for a passionate Director, GRA CMC Small Molecules to join our dynamic team. If you have a knack for regulatory affairs and are ready to lead and inspire, this role might be perfect for you!What we offer: Exciting...

  • Director, GRA CMC Small Molecules

    vor 1 Monat

    Zürich, Zürich, Schweiz Takeda Pharmaceuticals International AG Vollzeit

    Job DescriptionJoin our team and make a difference!Are you ready to take on a new challenge in the pharmaceutical industry? Takeda is looking for a passionate Director, GRA CMC Small Molecules to join our dynamic team. If you have a knack for regulatory affairs and are ready to lead and inspire, this role might be perfect for you!What we offer: Exciting...

  • Associate Director Regulatory Affairs, Marketed

    vor 1 Woche

    Zürich, Zürich, Schweiz Takeda 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: Collaborates to define, develop...

  • Regulatory Affairs

    vor 1 Woche

    Zürich, Zürich, Schweiz two Vollzeit

    For our Client Selectchemie AG we are looking for a Regulatory Affairs (CMC) Associate (100%) Finished Dosage Forms.About Selectchemie AGSelectchemie AG is an independent Swiss company and since 1969 a first class distributor and service provider for the global Pharma and Swiss Nutrition industries. As exclusive distributor for leading suppliers of raw...

  • Associate Director, Clinical Regulatory

    vor 1 Woche

    Zürich, Zürich, Schweiz Denali Therapeutics Vollzeit

    Associate Director, Clinical RegulatoryDenali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.The OpportunityResponsibilities Accountable for developing and implementing regulatory strategy for complex development...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zürich, Zürich, Schweiz Pfizer Vollzeit

    Regulatory Affairs Manager (M/F/d)time type: 60%/80%/100%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. Developing of...

  • Cmc Lead

    vor 1 Woche

    Zürich, Zürich, Schweiz Swisslinx Vollzeit

    On behalf of our client, an international Biotechnology company based in Switzerland, Swisslinx is looking for a CMC Lead.This senior leadership role will be responsible for project-specific Chemistry, Manufacturing and Control (CMC) teams accountable for plasma product development (PPD) projects. The primary responsibility and accountability of the role is...

  • Global QA/ra Manager

    vor 1 Woche

    Zürich, Zürich, Schweiz Barrington James Vollzeit

    Zürich District JOB TYPE Permanent EMP TYPE Full-Time EXPERTISE CMC SALARY TYPE Annually SALARY NegotiableAre you a highly skilled and experienced Quality Assurance and Regulatory Affairs professional with a specialisation in Chemistry, Manufacturing, and Controls (CMC) within the pharmaceutical industry? Are you passionate about ensuring the highest...

  • Regulatory Affairs Coordinator

    vor 1 Woche

    Zürich, Zürich, Schweiz Pfizer Vollzeit

    Weltweit arbeiten die Mitarbeiter von Pfizer gemeinsam daran, die Gesundheit eines jeden Einzelnen überall zu verbessern. Während wir Arzneimittel und Medizin-Produkte entwickeln und unser Geschäft global ausweiten, halten wir jederzeit Ausschau nach neuen Talenten. Derzeit suchen wir Sie an unserem Standort in Zürich als:Regulatory Affairs Coordinator...

  • Director, Eucan Regulatory Affairs Lead

    vor 1 Woche

    Zürich, Zürich, 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 assigned...

  • Global Patient Advocacy Associate Director

    vor 1 Woche

    Zürich, Zürich, Schweiz Novo Nordisk Vollzeit

    Global Patient Advocacy Associate DirectorCategory:Corporate AffairsLocation:Zurich, Switzerland Zurich, CH- Are you ready to establish meaningful relationships with patients, leveraging their insights to create value for the industry? Can you confidently represent our organization at congresses and engage in various communication platforms such as...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zürich, Zürich, Schweiz Sonova Vollzeit

    Who we areYou 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 unforgettable...