Associate Director
Vor 6 Tagen
Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**
**Your tasks in detail**:
- Provides regulatory operational support for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.
- Responsible for regulatory oversight of assigned clinical trials conducted in the region.
- Collaborates with all Takeda regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.
- Passion for quality in all areas of responsibility
- Leads and directs the work of others as part of a matrixed organization.
- Close collaboration with the RAV Europe Region Head (and Local Operating Company (LOCs) RA as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.
- In cooperation with key stakeholders and RAV Europe Region Head (and LOC RA as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Has a quality focus so that submissions are right-first-time.
- Supports overall content and management of local/regional regulatory components and filings e.g. MAA, MA variations. Contributes to local/regional label development and submission.
- Ensures compliance with both internal Takeda process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
- Supports RAV Europe Region Head in the preparation of health authority interactions/meetings in the region as applicable for specified projects
- Actively participate as member of teams within RAV supporting activities as assigned.
- Manages specific projects as assigned.
- Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
**Your profile**:
- BS, advanced scientific degree preferred.
- A minimum of 8 years of pharmaceutical industry experience, with a minimum of 6 years of regulatory experience.
- European regulatory experience is essential. Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval.
- Vaccines and/or biologics experience is preferred.
- Participation in Global regulatory filing is a plus.
- Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.
- Pays strong attention to quality, and is working reliably and thoroughly.
- Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross-functional teams; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
- Team player
**What you can look forward to with us**:
- Appreciative working atmosphere in an international and exciting working environment
- Independent work with the opportunity to play a part in shaping an innovative company
- Professional and personal development opportunities
- Flexible working hours and home office
**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.
**Locations**:
Zurich, Switzerland
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
-
Associate Director of Growth Initiatives
Vor 6 Tagen
Zürich, Zürich, Schweiz TN Switzerland VollzeitAbout the PositionWe are looking for a Senior Manager of Business Development to join our Strategic Resourcing Division (SRS) in Switzerland. As Associate Director of Business Development, you will focus on resourcing consultancy services and FSP Solutions.Your contributions will be instrumental to the company's ongoing success as we continue to...
-
Associate Director, Global Regulatory Affairs
Vor 4 Tagen
Zürich, ZH, Schweiz Takeda Pharmaceutical VollzeitThe Regulatory Affairs-Labeling, Associate Director is responsible for ensuring that Takeda gains regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of bringing better health to people...
-
Equity Associate Director
Vor 5 Tagen
Zürich, Zürich, Schweiz ACL Partners VollzeitA seasoned professional is sought by ACL Partners to fill the position of Equity Associate Director. As part of a high-performing team, the selected candidate will be responsible for spearheading investment initiatives and driving growth across diverse industries in Europe.Key Accountabilities:Leads financial analysis and modeling efforts to inform...
-
Associate Director Business Development
Vor 6 Tagen
Zürich, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:col-narrow-leftClient:TFS HealthScienceLocation:Job Category:Other-col-narrow-rightJob Reference:441f60987a37Job Views:3Posted:14.03.2025Expiry Date:28.04.2025col-wideJob Description:Are you passionate about building strong client relationships and identifying business opportunities? Do you thrive in dynamic...
-
Zürich, Zürich, Schweiz Proclinical Staffing VollzeitAbout the CompanyProclinical Staffing is a leading life sciences recruiter dedicated to connecting exceptional professionals with the most suitable opportunities worldwide. Our commitment to excellence has earned us a reputation as a trusted partner in finding top talent for our clients.About the JobWe are seeking an experienced Associate Director of Partner...
-
Associate Director, Partner Markets
vor 2 Wochen
Zürich, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Client:ProclinicalLocation:Not specifiedJob Category:OtherJob Reference:b7b6f05470caJob Views:4Posted:03.03.2025Expiry Date:17.04.2025Job Description:Proclinical is seeking an experienced Associate Director of Partner Markets to manage and drive partnerships in countries outside the US and Europe. This role offers...
-
Associate Director
Vor 7 Tagen
Zürich, Zürich, Schweiz Aequor Consulting GmbH VollzeitAequor Consulting GmbH is a leading consulting firm specializing in treasury technology and risk management. We are seeking an Associate Director - Treasury Solutions to join our team.About the RoleIn this role, you will lead complex, transformational initiatives in global treasury management, working closely with clients to advise on key treasury, risk...
-
Associate Director
vor 3 Wochen
Zürich, Schweiz TN Switzerland VollzeitAssociate Director - IT Manufacturing, ZürichZürich, SwitzerlandDescriptionAbout the role:The Associate Director - IT Manufacturing is responsible for overseeing and managing all services that enable applications and operations at the shopfloor level of manufacturing production lines. This role involves establishing strategic direction and creating...
-
Associate Director
vor 2 Wochen
Zürich, Schweiz TN Switzerland VollzeitAssociate Director - IT Manufacturing, Zürich DistrictZürich District, SwitzerlandDescriptionAbout the role:The Associate Director - IT Manufacturing is responsible for overseeing and managing all services that enable applications and operations at the shopfloor level of manufacturing production lines. This role involves establishing strategic direction...
-
Investor relations associate
Vor 7 Tagen
Zürich, Schweiz Mason Blake VollzeitJob details Location Date Posted 24 March 2021 Category Distribution Job Type Permanent Job ID J17394 Competitive package Description This is an excellent opportunity with a global Asset Management firm that is expanding their European Distribution team. The Investor Relations Associate is a central position, with the primary...
-
Associate Director, Partner Markets
vor 2 Wochen
Zürich, Schweiz Proclinical Staffing VollzeitGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Proclinical StaffingLead Consultant, Commercial/HEOR & Market Access at Proclinical StaffingProclinical is seeking an experienced Associate Director of Partner Markets to manage and drive partnerships in countries outside the US and Europe. This role offers an...
-
Associate Store Director
Vor 3 Tagen
Zürich, Zürich, Schweiz On VollzeitAs an Associate Store Leader, you will be responsible for leading the development and management of our retail store in Zurich. Your key responsibilities will include team development and performance management, overseeing inventory management, leading change management efforts, and crafting effective communications.Your ResponsibilitiesBack of House: Lead...
-
Zürich, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Client:TakedaLocation:Cambridge, MAJob Category:OtherJob Reference:365b75b92a34Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Job Title: Associate Director, Clinical Quality ComplianceAbout the role:As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the...
-
Director of Business Strategy
Vor 6 Tagen
Zürich, Zürich, Schweiz TN Switzerland VollzeitAbout the RoleWe are seeking an experienced professional to join our team as a Director of Business Strategy in Switzerland. As Associate Director of Business Development, you will be responsible for executing business development strategies for Switzerland.Key responsibilities include:Identifying and pursuing new business opportunities within the Swiss...
-
Associate Director of Technology Innovation
Vor 7 Tagen
Zürich, Zürich, Schweiz ZS VollzeitBusiness Technology - Associate PrincipalWe're looking for a strong Technology Leader who excels in operating at the intersection of delivery excellence and business development. You'll be a senior Technology advisory and consulting leader with 12+ years of experience in selling and implementing multiple client engagements involving Data solution...
-
Medical Director
vor 2 Wochen
Zürich, Schweiz Meet VollzeitGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Meet Life SciencesClinical Development Expert | Associate Recruiter at MeetFreelance Medical Director – Pharmaceuticals | 12-Month Contract | SwitzerlandWe are looking for an experienced Medical Director for one of our trusted business partners operating in the...
-
Zürich, Schweiz FGS Global (Europe) GmbH VollzeitWith over 1,400 team members in 31 offices across three continents, FGS Global is one of the world's leading strategic communications consultancies. In Europe, we are a team of more than 450 employees spread across 10 cities including Amsterdam, Berlin, Brussels, Frankfurt, London, Paris, The Hague and Zurich. Our clients range from scale-ups to listed...
-
Senior Investment Manager
vor 1 Woche
Zürich, Schweiz TopRecroot VollzeitDirect message the job poster from TopRecrootAssociate Director @ TopRecroot | Investment Banks & M&A and Private Equity & Venture CapitalOur client, an international and well-established Investment Company, is looking for Investment Senior Investment Manager / Director professionals to join their team in Switzerland.Responsibilities:Deal Sourcing: Identify...
-
Director Executive Compensation
Vor 2 Tagen
Zürich, Zürich, Schweiz WTW VollzeitThe Executive Compensation & Board Advisory (ECBA) practice is part of the Work & Rewards segment, and our practice focuses on aligning corporate strategy, mission, vision, and corporate values with executive compensation design. WTW is the global leader in executive compensation consulting, with over 500 consultants worldwide. Our consultancy services are...
-
Senior Investment Manager
vor 3 Wochen
Zürich, Schweiz WhatJobs VollzeitAssociate Director @ TopRecroot | Investment Banks & M&A and Private Equity & Venture Capital Our client, an international and well-established Investment Company, is looking for Investment Senior Investment Manager / Director professionals to join their team in Switzerland. Responsibilities: Deal Sourcing : Identify and evaluate potential investment...
