Regulatory Science Nonclinical Lead

vor 1 Woche

Geneve, Schweiz JTI - Japan Tobacco International Vollzeit

We’re JTI, Japan Tobacco International and **we believe in freedom**. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our **consumers to choose from**. It’s how we’ve grown to be present in 130 countries.

But our business isn’t just business. Our business is our people. Their talent. Their potential. We believe **when they’re free** to be themselves, grow, travel and develop, **amazing things can happen for our business**.

That’s why our employees, from around the world, choose to be a part of JTI.** It is why 87% of employees feel happy working at JTI.** And why we’ve been awarded **Global Top Employer status, eight years running**.

So when you’re ready to choose a career you’ll love, in a company you’ll love, feel free to #JoinTheIdea.

**REGULATORY SCIENCE NONCLINICAL LEAD**

**What this position is about - Purpose**:
Reporting to the VP of Regulatory Science and under their leadership, Regulatory Science Nonclinical Manager is accountable for providing operational and strategic guidance for all nonclinical toxicological assessments that will be conducted as part of JTI's Regulatory Science Strategy. She / He will lead the execution of all externally conducted nonclinical toxicological assessments with accountability for the overarching regulatory scope, testing approach, and development of associated protocol templates. She / He is accountable for monitoring and cascading best practices for the testing of JTI's Reduced Risks Products across all Regulatory Science nonclinical initiatives. The individual will review and sign-off the nonclinical sections of associated regulatory submissions.

**What will you do - Responsibilities**:
Working with the Regulatory Science VP and other team members to execute nonclinical Regulatory Science initiatives:

- Overseeing contracting, protocol development and execution of nonclinical studies conducted at Clinical Research Organizations which includes but is not limited to HPHC analyses, leachable and extractables, microbiology and in vitro and in vivo toxicology studies
- Is accountable for evaluating and mitigating issues relevant to nonclinical studies, including the interpretation of results, writing and issuance of final reports, timeline changes, and data integrity and/or quality issues
- Is a primary representative for assigned nonclinical study teams and represent Regulatory Science cross-functionally
- Monitors and cascades Reduced Risk Products testing best practices across all Regulatory Science nonclinical initiatives
- She / He is accountable for the sign-off on nonclinical sections of associated regulatory submission documentation
- She / He is accountable for developing and having total oversight of Regulatory Science internal nonclinical processes, including the development of Standard Operating Procedures and policies, study oversight, and training

Accountable for providing strategic guidance on nonclinical challenges and future developments in the JTI planning processes:

- Provides strategic input to Regulatory Science nonclinical operations activities (internal and external meetings, investigator meetings, discussions with vendors/third parties, budgets)
- Anticipates and reports nonclinical and regulatory industry trends
- Benchmarks Regulatory Science research activities, leads analysis of the competitive landscape and the regulatory environment, developing future Regulatory Science nonclinical proposal

Influences and provides awareness to other related internal business functions on the requirements and approach of the RRP Strategy:

- Confirms Regulatory Science strategic priorities, deprioritizes less important deliverables
- Steps in, when ARCI (Accountability, Responsibility, Consulted, Informed) between functions is not 100% clear, providing the most efficient solution(s)
- Contributes to OCM and SCM updates
- Identifies and communicates pertinent Program and regulatory priorities to JTI's cross-functional teams

Interacting with other JTI functions to respond to regulatory and product compliance challenges:

- Acts as Key Regulatory Science contact, providing insights and expertise to cross-functional project teams
- Contributes to formal responses to regulatory inquiries and compliance challenges
- Monitors and disseminates nonclinical regulatory developments, advising on their impact to JTI's business
- Is a Key participant for Regulatory Science in scientific engagement development activities (e.g. publications, presentations)

**Who are we looking for - Requirements**:

- Degree (Science) preferably to PhD or professional doctorate (e.g., MD, DVM, PharmD) level; Board certified: DABT or equivalent (ERT) required
- 3+ years’ experience working in a multinational organization in a highly regulated industry (Tobacco, Pharma, medical devices) with experience conducting/managing pre-clinical studie

  • Regulatory Science Nonclinical Manager

    vor 1 Woche

    Geneve, Schweiz JTI - Japan Tobacco International Vollzeit

    We’re JTI, Japan Tobacco International and **we believe in freedom**. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our **consumers to choose from**. It’s how we’ve grown to be present in 130 countries. But our business isn’t just...

  • Regulatory Human Behavioral Scientist

    vor 1 Woche

    Geneve, Schweiz JTI - Japan Tobacco International Vollzeit

    We’re JTI, Japan Tobacco International and **we believe in freedom**. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our **consumers to choose from**. It’s how we’ve grown to be present in 130 countries. But our business isn’t just...

  • Regulatory Affairs Clinical Manager

    Vor 7 Tagen

    Geneve, Schweiz OM Pharma Ltd. Vollzeit

    Location: Meyrin, Geneva, CH- Division: - Division: Regulatory Affairs- Job Type: Permanent roleIn view of our continued global growth, we are recruiting a** Regulatory Affairs Clinical Manager** at our headquarters in Geneva. Reporting to the Regional Regulatory Affairs Head EU/CH/US, your mission is to provide regulatory support to the clinical operations...

  • Global Regulatory Manager

    Vor 2 Tagen

    Geneve, Schweiz FMC Corporation Vollzeit

    **Global Regulatory Manager** - Strategic mindset and collaborative behavior are key. Join a dedicated team of professionals!_ - This role can be based in Hørsholm, Denmark, Geneva, Switzerland, Frankfurt, Germany, Lyon, France or Harrogate, UK._ **About FMC** FMC Corporation is a leading specialty company focused on agricultural technologies. FMC...

  • Head Regulatory Affairs Cmc

    vor 17 Stunden

    Geneve, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for a Head Regulatory Affairs CMC to join a fantastic pharmaceutical organisation on a permanent basis located in Geneva. Our client is focused on creating products and offering services that are used within the therapy and care of those who are chronically ill. Please note that to be considered for this role you must have the right...

  • Scientific Regulatory Affairs

    Vor 7 Tagen

    Geneve, Schweiz JTI - Japan Tobacco International Vollzeit

    We’re JTI, Japan Tobacco International and **we believe in freedom**. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our **consumers to choose from**. It’s how we’ve grown to be present in 130 countries. But our business isn’t just...

  • Cmc Program Lead

    Vor 2 Tagen

    Geneve, Schweiz Alentis Therapeutics AG Vollzeit

    **Job Profile**: The CMC Program Lead is responsible for contributing strategically to CMC development planning and executing the CMC strategy for Alentis monoclonal antibody products. The position includes the management of CMC project manager, the oversight of the outsourced CMC activities (such as cell line development and banking, USP/DSP/formulation...

  • Phd Position in First Language Acquisition Research

    Vor 3 Tagen

    Geneve, Schweiz Department of Comparative Language Science Vollzeit

    Department of Comparative Language Science_ **PhD Position in First Language Acquisition Research** The NCCR is a Swiss National Center of Competence in Research with the goal of creating a new discipline, Evolutionary Language Science, that targets the past and future of language. The center consists of leading scientists from traditionally separated...

  • Cmc Project Manager

    Vor 2 Tagen

    Geneve, Schweiz Alentis Therapeutics AG Vollzeit

    **Job Profile**: The CMC operations project manager is responsible for coordinating, planning, managing and administering the outsourced CMC activities for Alentis monoclonal antibody products. The position includes and the preparation of CMC regulatory dossiers. His function will report to the CMC Program Lead. **Responsibilities**: **Technical**: -...

  • Medical Device Lead Auditor

    vor 1 Woche

    Geneve, Schweiz SGS Vollzeit

    **Company Description** SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97’000 employees, SGS operates a network of over 2 650 offices and laboratories around the world. **Job Description** Primary Responsibilities** - As the...

  • Cmc Manager

    Vor 3 Tagen

    Geneve, Schweiz Stalicla SA Vollzeit

    STALICLA is an international and fast-growing biopharmaceutical company on a mission to build a new therapeutic space for patients with disorders of the developing brain. As the company is rapidly scaling, STALICLA is looking to recruit a seasoned and agile PreClinical Safety Expert to support the next stages of the company’s development. **CMC...

  • Global Medical Affairs Lead

    Vor 3 Tagen

    Geneve, Schweiz OM Pharma Ltd. Vollzeit

    Location: Meyrin, Geneva, CH- Division: - Division: Medical Affairs- Job Type: Permanent roleWe are recruiting a** Global Medical Affairs Lead** to strengthen our headquarters and biotech production site in Geneva. Reporting to the Head of Global Medical Affairs, your mission is to identify medical unmet needs and define the global medical affairs strategy...

  • Api Deputy Lead

    Vor 3 Tagen

    Geneve, Schweiz World Economic Forum LLC Vollzeit

    The World Economic Forum, committed to improving the state of the world, is the International Organization for Public-Private Cooperation. The Forum engages the foremost political, business and other leaders of society to shape global, regional and industry agendas. The Forum is building world-leading digital collaboration platforms, knowledge and data...

  • Technical Lead, Paediatric Hiv

    Vor 7 Tagen

    Geneve, Schweiz International AIDS Society Vollzeit

    **About the IAS**: **IAS - the International AIDS Society - convenes, educates and advocates for a world in which HIV no longer presents a threat to public health and individual well-being.** After the emergence of HIV and AIDS, concerned scientists created the IAS to bring together experts from across the world and disciplines to promote a concerted HIV...

  • Private Banker Team Leader

    vor 1 Woche

    Geneve, Schweiz Citi Vollzeit

    The Private Banker’s role is to develop and deliver private and investment banking services to Ultra High Net Worth (UHNW) client’s within Switzerland Onshore market defined as UHNW domiciled in Switzerland, UK RND ,single and multi Family offices based in Switzerland. UHNW is defined as clients with USD 25+ million Net Worth or USD 10+ million AUM or...

  • Pms Complaints Manager

    Vor 6 Tagen

    Geneve, Schweiz Axepta SA Vollzeit

    We are looking for a **PMS Complaints Lead**, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices, located in Geneva. **Responsibilities**: - PMS Complaints management_ - Oversee the Case Management activities including triage and reportability assessment - Oversee Quality Review and Medical Case Assessment of...

  • Pms Complaints Manager

    Vor 2 Tagen

    Geneve, Schweiz Axepta SA Vollzeit

    We are looking for a **PMS Complaints Lead**, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices. **Responsibilities**: PMS Complaints management - Oversee the Case Management activities including triage and reportability assessment - Oversee Quality Review and Medical Case Assessment of the customer...

  • Shift Leader

    vor 1 Woche

    Geneve, Schweiz ELCA Security Vollzeit

    This opportunity is based in Geneva **Shift Leader (L3)**: Senthorus is a SOC entity that will serve the Swiss market with world-class managed security solutions, from Switzerland, with all data remaining in Switzerland, for Swiss and European clients. **This position is based in Geneva** **and requires working on shift mode** **In this role**: Senthorus...

  • Shift Leader

    Vor 2 Tagen

    Geneve, Schweiz ELCA Vollzeit

    Critères de l'offre Description du poste Senthorus is looking for a Shift Leader (L3) to help our global customers manage their IT security. You will play a vital role and be part be part of a fast-paced team that helps customers to reduce the impact of security incidents and ensures that critical business operations continue...

  • Manufacturing Science and Technology

    vor 17 Stunden

    Geneve, Schweiz OM Pharma Ltd. Vollzeit

    Location: Meyrin, Geneva, CH- Division: - Division: Industrial Development- Job Type: Permanent roleFollowing an internal transfer, we are recruiting a** Manufacturing Science and Technology (MSAT) Scientist** at our headquarters and biotech production site in Geneva. Reporting to the Head of MSAT and working in close collaboration with different departments...