Director, Global Regulatory Affairs Cmc Alliance
vor 1 Woche
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 Head of GRA CMC for MPD, CMC Sourcing and Due Diligence, you partner closely across the organization to influence as a key opinion leader within Takeda, providing consistent messaging on Takeda's scope of regulatory within the Contract Manufacturing Business (CMB) for downstream efficiency proceeding complexity of divestment decisions, and align on ways of working for Takeda alliance partnered products.
How you will contribute:
- Evaluate change proposals for global regulatory impact and plan global variations and amendments.
- Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
- Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and review content for conformance with established requirement.
- Ensures project team, 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. Provide solutions to prevent recurrence of issues.
- Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
- Maintain constructive relations with essential colleagues, e.g., colleagues within Takeda, Alliance Partners, and Health Authority representatives.
What you bring to Takeda:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Experience with active pharmaceutical ingredient/drug substances, drug products, biologics, analytical characterization, process scaleup or regulatory registration of products is required.
- Expert in developing alternate strategies based on guidance/regulations.
- Expert in liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings. International experience preferred.
- Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Able to provide sound strategic advice and enable critical decisions under ambiguity.
- Demonstrate leadership, problemsolving ability, flexibility, and values teamwork.
- Demonstrate strategic enterprise thinking, with the ability to influence at all levels in a complex matrix environment.
- Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
- Good judgement in elevating and communicating actual or potential issues to line management.
- Builds and maintains a team environment that inspires and enables people to move the organization forward.
- Expert in CTD authoring and/or review skills throughout the product lifecycle, with a solid understanding of global submission complexities.
Travel Requirements:
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 1030% travel.
Locations:
Zurich, Switzerland
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
-
Zürich, Zürich, Schweiz ARIAD VollzeitJob 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...
-
Director, Global Regulatory Affairs Cmc
vor 1 Woche
Zürich, Zürich, Schweiz Takeda Pharmaceutical VollzeitJoin 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...
-
Zürich, Zürich, Schweiz ARIAD VollzeitJob 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 VollzeitJoin 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...
-
Zürich, Zürich, Schweiz Takeda VollzeitDescription 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...
-
Zürich, Zürich, Schweiz Takeda VollzeitBy 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...
-
Zürich, Zürich, Schweiz Takeda Pharmaceuticals International AG VollzeitBy 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...
-
Associate Director, Global Regulatory Affairs CMC
vor 3 Wochen
Zürich, Zürich, Schweiz Takeda Pharmaceuticals International AG VollzeitBy 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...
-
Director, Cmc Regulatory Compliance
vor 1 Woche
Zürich, Zürich, Schweiz Takeda VollzeitAt 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 VollzeitJob 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 VollzeitJob 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...
-
Regulatory Affairs Manager
vor 1 Woche
Zürich, Zürich, Schweiz Pfizer VollzeitRegulatory 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...
-
Regulatory Affairs
vor 1 Woche
Zürich, Zürich, Schweiz two VollzeitFor 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...
-
Cmc Lead
vor 1 Woche
Zürich, Zürich, Schweiz Swisslinx VollzeitOn 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 VollzeitZürich 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 VollzeitWeltweit 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...
-
Associate Director Regulatory Affairs, Marketed
vor 1 Woche
Zürich, Zürich, Schweiz Takeda VollzeitAre 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...
-
Director, Eucan Regulatory Affairs Lead
vor 1 Woche
Zürich, Zürich, Schweiz Takeda Pharmaceutical VollzeitOur 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...
-
Regulatory Affairs Manager
vor 1 Woche
Zürich, Zürich, Schweiz Sonova VollzeitWho 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...
-
Cmc Scientist and Digital Enabler
vor 1 Woche
Zürich, Zürich, Schweiz Swisslinx VollzeitOn behalf of our client, an international Biotechnology company based in Switzerland, Swisslinx is looking for a CMC Scientist and Digital Enabler. This is initially a 12-months contract position (afterwards an extension for another year) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working...