Anmelden, um alle Funktionen unseres Dienstes zu nutzen.
  • Suche nach Stellenangeboten
  • Favoriten
  • Lebenslauf erstellen
    Neu
  • Gehälter
  • Job-Newsletter

Executive Director, Regulatory Strategy

Neurocrine Biosciences

Responsibilities

  • Lead regulatory strategy and execution across product lifecycle for therapeutic area programs
  • Represent regulatory perspective at therapeutic area and enterprise governance forums
  • Provide strategic oversight and hands-on execution for programs from early phase to post-marketing
  • Guide senior management on complex regulatory issues and translating requirements into business strategy
  • Develop and maintain external relationships with regulators and industry peers

Requirements

  • Bachelor's degree in life science plus 17+ years biopharma/regulatory experience with leadership background
  • Master's degree preferred with 15+ years related biopharma and regulatory experience
  • PhD with 12+ years related biopharma and regulatory experience
  • Expert-level knowledge of regulatory environment and therapeutic area strategy
  • Proven track record directing regulatory teams through complex multi-program portfolios
  • Ex-US CTA and US marketing application filing experience required
  • Demonstrated ability to build and mentor high-performing teams and develop future leaders
Die Stellenanzeige wurde vor Vor 25 Tagen veröffentlicht
Ähnliche Jobs, die für Sie interessant sein könntenBasierend auf das Stellenangebot Executive Director, Regulatory Strategy in Allschwil BL
  •  ...Responsibilities Lead statistical strategy for real-world evidence and health outcomes studies across departments Develop protocols...  ...in real-world evidence applications across clinical, regulatory, and payer contexts Knowledge of global regulatory and HTA... 
    Empfohlen

    Neurocrine Biosciences

    Allschwil BL
    Vor 25 Tagen
  •  ...ongoing investigator relationships Assess adverse events and evaluate safety of compounds throughout trial duration Set regulatory strategy for FDA and other authorities; manage all submissions and interactions Develop clinical trial infrastructure, identify... 
    Empfohlen

    Neurocrine Biosciences

    Allschwil BL
    Vor 25 Tagen
  •  ...Responsibilities Develop clinical QA strategy and establish stakeholder relationships to achieve GCP compliance Build and lead...  ...systems and ensure study compliance Lead preparations for regulatory inspections including mock inspections and readiness planning... 
    Empfohlen

    Neurocrine Biosciences

    Allschwil BL
    Vor 25 Tagen
  •  ...Responsibilities Develop clinical pharmacology and quantitative strategies for assigned therapeutic areas supporting development...  ...clinical pharmacology expertise to cross-functional teams for regulatory submissions Represent company as subject matter expert at regulatory... 
    Empfohlen

    Neurocrine Biosciences

    Allschwil BL
    Vor 25 Tagen
  •  ...required .   ~ Review IRT strategy to ensure it supports the...  ...global and regional supply strategies to ensure continuity of subject...  ...cGMPs , GCPs, and other regulatory requirements and ensure study...  ...clinical program design and execution.  ~ Understanding of... 
    Empfohlen
    Homeoffice
    Vollzeit
    Remote job
    Allschwil BL
    Vor 10 Tagen
  •  ...clinical trials. The role coordinates with trial teams to ensure data integrity, patient safety, regulatory compliance, and inspection readiness throughout trial execution. Responsibilities Identify, assess, and advise on mitigation of quality risks affecting trial... 

    Johnson & Johnson

    Allschwil BL
    Vor 6 Tagen
  •  ...recording, and storing materials while maintaining compliance with regulatory guidelines and managing inventory systems. Standard Monday-...  ...and WMS transactions Physically store materials and execute required inventory movements Operate material handling machinery... 

    Thermo Fisher Scientific

    Allschwil BL
    Vor 15 Tagen
  •  ...Senior Manager or Associate Director leading the European Health Data Space data cataloguing initiative within Johnson & Johnson's Clinical...  ...Deep knowledge of clinical data, health data standards, and regulatory requirements Demonstrated ability to lead cross-functional... 

    Johnson & Johnson

    Allschwil BL
    Vor 17 Tagen
  •  ...equipment. The role requires independent work within GMP and regulatory guidelines, technical support to operations, and continuous improvement...  ...Provide technical support to operations during order execution and troubleshoot failures Identify and propose improvements... 
    Schichtarbeit

    Thermo Fisher Scientific

    Allschwil BL
    Vor 4 Tagen
  •  ...management plans for study drugs in global clinical trials. This role involves forecasting supply strategies, coordinating with cross-functional teams, and ensuring regulatory compliance for pharmaceutical and biotech clients. Responsibilities Design and implement... 

    Thermo Fisher Scientific

    Allschwil BL
    Vor 21 Tagen
  •  ...Johnson & Johnson seeks a Submissions & Regulatory Intelligence Manager in Allschwil,...  ...Switzerland to lead clinical data standards strategy and regulatory compliance efforts. The...  ...and implement clinical data standards strategies Strong communication skills across multiple... 

    Johnson & Johnson

    Allschwil BL
    Vor 4 Tagen
  •  ...activities aligned with manufacturing priorities Support inspection execution when operationally required Provide visibility on...  ...operations is considered an asset ~ Strong knowledge of GMP and regulatory requirements ~ Strong organizational and prioritization... 
    Homeoffice
    Überstunden
    Vollzeit
    Schichtarbeit
    Allschwil BL
    Vor 16 Tagen
  •  ...Revolution Medicines seeks a Director of CMC Regulatory for Europe to develop and execute regional regulatory strategies supporting clinical trials, marketing authorizations, and lifecycle management. The role requires deep expertise in EU regulatory frameworks and leadership... 

    Revolution Medicines

    Basel BS
    Vor 11 Tagen
  •  ...Revolution Medicines seeks a Director of Regulatory Affairs to lead European regulatory strategy and execution for oncology programs. The role involves...  ...regional and global regulatory strategies. Responsibilities Develop and execute European regulatory pathways for... 

    Revolution Medicines

    Basel BS
    Vor 11 Tagen
  • CHF 179200 pro Jahr

     ...innovative medicines on a global scale? As Executive Director Pricing & Contracting, you will play a...  ..., driving pricing and contracting strategies that maximize patient access and...  ...organizational excellence. Develop and execute global pricing and contracting... 
    Flexible Arbeitszeit

    General Management

    Basel BS
    Vor 14 Tagen
  •  ...Johnson seeks a Principal C&SP Methodology Lead to drive technical strategy and innovation in clinical and statistical programming. This...  ..., R, or similar analytical programming languages Experience with data management, analysis, and regulatory submission workflows... 

    Johnson & Johnson

    Allschwil BL
    Vor 17 Tagen
  •  ...Revolution Medicines seeks a Director of Regulatory Affairs for its Basel, Switzerland office to lead regulatory strategy and compliance for assigned oncology products. The role...  ...submissions and pre-submission strategies Experience managing regulatory inspections... 

    Revolution Medicines

    Basel BS
    Vor 2 Tagen
  •  ...Revolution Medicines seeks a Director of Regulatory Affairs Labelling for Europe to lead labelling strategy and execution across EU/EEA, UK, and Switzerland for oncology programs...  .... Responsibilities Develop and execute EU labelling strategy aligned with global... 

    Revolution Medicines

    Basel BS
    Vor 11 Tagen
  •  ...Revolution Medicines seeks an Associate Director of Regulatory Affairs for its European operations. This...  ...-functional teams to advance regulatory strategies aligned with company objectives. Responsibilities Develop and execute regulatory strategies for oncology... 

    Revolution Medicines

    Basel BS
    Vor 11 Tagen
  • Summary The Novartis Strategy & Growth, Therapeutic Area Strategy team for Neuroscience is seeking a new Therapeutic Area Strategy Director who will support the creation and update of a holistic TA strategy; provide early-phase commercial insights to project... 
    Temporär

    Strategic Planning & BD&L

    Basel BS
    Vor einem Monat
  •  ...Switzerland Build and Lead Internal Regulatory Affairs Capabilities for Late-Stage Development...  ...and coordinate the global regulatory strategy for late-stage clinical development,...  ...understanding of filing readiness and submission execution. Proven experience supporting... 

    Gloor&Lang

    Basel BS
    vor 2 Monaten
  •  ...day-to-day operations of manufacturing, packaging, or warehouse operations while ensuring compliance with quality standards and regulatory requirements. Guide operational excellence through continuous improvement initiatives to achieve safety, quality, delivery, and financial... 
    Homeoffice
    Vollzeit
    Schichtarbeit
    Allschwil BL
    Vor 1 Tag
  •  ...strategic and daily operations of manufacturing, packaging, and warehouse functions Ensure compliance with GMP standards and regulatory requirements across operations Lead continuous improvement initiatives to achieve safety, quality, delivery, and financial targets... 

    Thermo Fisher Scientific

    Allschwil BL
    Vor 11 Tagen
  •  ...high-bay warehouse picking activities and related WMS transactions Physically store materials and perform GPMS/WMS postings Execute required material movements, including transfers to external storage locations Operate machinery and equipment used for material... 
    Homeoffice
    Vollzeit
    Allschwil BL
    Vor 14 Tagen
  •  ...seeks a Commercial Director for Switzerland to lead...  ...local commercial strategy and execution for its oncology portfolio...  ...Define and execute local commercial strategy...  ...brand and portfolio strategies tailored to Swiss...  ...payer dynamics, and regulatory environment Cross... 

    Revolution Medicines

    Basel BS
    Vor 11 Tagen
  •  ...experienced HEOR/HTA & Evidence Strategy Manager (Hematology) to lead...  ...cross-functional JCA planning and execution across Market Access, Clinical Development, Regulatory Affairs, Safety, Medical...  ...and implementation of evidence strategies to address JCA, HTA, reimbursement... 
    Temporär
    Remote job

    Michael Page

    Basel BS
    Vor 23 Tagen
  •  ...Medicines seeks an Associate Director of Marketing for...  ...launches, brand strategy, and customer engagement...  ...orchestrates cross-functional execution across marketing,...  ...market Develop and execute promotional mix and compliant...  ...Swiss/European healthcare and regulatory environment... 

    Revolution Medicines

    Basel BS
    Vor 4 Tagen
  •  ...contributing to supply chain operations. Working closely with internal teams and clients, you will help ensure smooth project execution, timely delivery, and high-quality service. The role focuses on project coordination, stakeholder communication, and operational support... 
    Homeoffice
    Vollzeit
    Festanstellung
    Allschwil BL
    Vor 15 Tagen
  •  ...chain operations and ensure timely delivery of services Communicate with internal teams and external clients to facilitate project execution Track data, support reporting, and maintain compliance with GMP standards Manage multiple concurrent activities while... 

    Thermo Fisher Scientific

    Allschwil BL
    Vor 18 Tagen
  •  ...The mechanic is responsible for the timely changeover/setup of machines as well as technical support of Operations during order execution. They are responsible for ensuring that machines are maintained, calibrated, and repaired on time. Responsibilities Independent... 
    Homeoffice
    Vollzeit
    Schichtarbeit
    Allschwil BL
    Vor 3 Tagen

Wollen Sie mehr Stellenangebote erhalten?

Abonnieren Sie und erhalten Sie ähnliche Stellenangebote wie Executive Director, Regulatory Strategy. Seien Sie der Erste, der sich bewirbt!