Senior Director – Global Regulatory Strategy Biologics Job at NonStop Consulting (Geneva)

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to l...

Location

Salary:

245000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
Experience with regulatory filing preparation and messaging across global jurisdictions
Deep knowledge and understanding of relevant global regulatory guidance and requirements
Ability to keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel up to 30%

Job Responsibility

Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing
in-process/release/stability testing
specification justification and maintenance
shelf-life management
and critical documentation
Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Senior Director Immunology

The Senior Director Immunology will lead discovery, preclinical development, and...

Location

United States , Sioux Falls

Salary:

Not provided

SAB Biotherapeutics

Expiration Date

Until further notice

Requirements

PhD with 10+ years’ experience in Immunology or related field, with biotech/pharma industry experience required
Deep expertise in immunology, T-cell biology, autoimmune mechanisms, and therapeutic antibodies
Proven proficiency in clinical immunophenotyping, particularly advanced flow cytometry
Strong record of accomplishment in advancing immunology-focused therapeutics and leading translational/biomarker initiatives
Experience managing laboratory scientists and analytical teams
Skilled in molecular and cellular assay development within industry settings
Familiarity with global regulatory pathways (FDA, EMA, MHRA, TGA)
Highly collaborative, innovative, with strong written and spoken communication skills and ability to lead in a matrixed, distributed environment
High level of emotional intelligence and the demonstrated ability to be an effective listener with strong diplomacy and presentation skills
Previous experience meeting with and presenting to internal and external stakeholders to include, but not limited to BOD, investors, analysts and at industry conferences

Job Responsibility

Oversee the design, execution, and validation of biomarker discovery, flow-based immunophenotyping, and patient-stratification assays for clinical trials
Direct experimental planning and data analysis, ensuring high-quality data interpretation, reporting, and communication to internal stakeholders and governance bodies
Partner with translational, clinical, regulatory, and development teams to integrate biomarker and assay strategies into protocols, regulatory documents, and clinical plans
Provide strategic leadership across Research and Translational Immunology, guiding disease biology insights, mechanism-of-action studies, and biomarker-enabled clinical strategies
Participate in translational and biomarker planning for discovery through clinical stages, including immunophenotyping, pharmacodynamic analyses, and molecular/cellular profiling
Manage and collaborate with CROs, external vendors, and academic partners to support assay development, method innovation, and data generation
Foster an excellent research environment, supporting lab-based teams in culture, collaboration, operations, and safety
Represent Translational Science and Immunology internally and externally, presenting scientific findings and program progress. This includes presenting to investors, analysts and at industry conferences
Identify and pilot innovative technologies to enhance translational science and immunotherapy development
Ensure compliance with global regulatory standards (FDA/CBER, EMA, MHRA, TGA) and maintain awareness of scientific and technical advancements relevant to autoimmune drug development

Fulltime

Global Study Director - Hematology/Oncology - Cell Therapy

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States; Canada , Montreal; Cary; Burlington; Blue Bell; Philadelphia; Pittsburgh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
Proven project management experience and training
At least 7 years of clinical trial experience
At least 3 years of experience in global study leadership and team leadership
Demonstrated clinical trial expertise in Hematology - Oncology
Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery
startup, maintenance and close out
Thorough understanding of the cross-functional clinical trial process eg. Data flow
Strong strategic and critical thinking abilities
Proven skillset and abilities in complex problem solving and decision-making

Job Responsibility

Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection
Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required
Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended)
Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant
Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Director, Privacy R&D and CPO

A Director Privacy for R&D/CPO ensures compliance with global data protection la...

Location

Belgium; United Kingdom , Wavre; London

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Expertise in essential regulation guidelines and medical governance policies and procedures applicable to R&D
Broad scientific/ pharmaceutical industry background with more than 10 years of experience in privacy EU and ex EU
Previous experience in implementing / embedding Privacy risk controls into a worldwide organization
Proven success in developing and executing activities that improve the application of the internal control framework
Good understanding of privacy regulatory framework
Relevant experience in governance type activities with understanding of the R&D, medical, commercial and compliance functions.

Job Responsibility

Develop and implement a strategy to ensure Privacy by Design into R&D & CPO processes. This includes completing new or adjusting existing privacy inventories and/or privacy risk assessments and developing and implementing mitigating controls
Oversee the privacy strategy to ensure timely create and review existing R&D & CPO privacy inventories and privacy impact assessments to identify gaps, assign appropriate actions, and track actions to completion. Ensure new innovative areas are timely addressed and risk identified including adequate review of third-party global process relevant to the enterprise risk
Provide inventory and monitor R&D/CPO privacy gaps, risks and issues as well as developing adequate risk minimization measures, corrective and preventative actions. Provide status updates to senior governance bodies such as R&D’s Risk Management and Compliance Board (RDCB) and Data Ethic and Governance Council as well as CPO related board
Support the design of privacy-related training for R&D & CPO staff to foster a privacy by design culture
Analyze and implement process changes required to enhance R&D/CPO Privacy framework
Maintain ongoing communication with relevant LOC stakeholders, Privacy Legal, Data Privacy Officer and enterprise risk ensuring continued alignment between global and local R&D/CPO Privacy processes
Coordinate efforts with the privacy lead needed to respond to Data Privacy Regulators in the event of Data Privacy Breaches. Monitor frequency and resolution of breach as well as implement remediation strategy to avoid recurrence. Coordinate with privacy lead responses to Individual Rights Management requests, ensuring engagement of the right R&D stakeholders in the information collection
Oversee and ensure adequate privacy expertise related to the data and human biological sample reuse (including adequate support to the DSAP panel)
Create and maintain R&D/CPO’s approach to the GSK Privacy Enterprise Risk Plan and maintain ongoing communication with Privacy professionals in other GSK business areas as well as maintain the R&D/CPO privacy champion network
Provide Risk Management expertise and oversight for R&D/CPO Privacy covering all therapy areas and with global-regional-local span

Fulltime

New

Lawson Senior AP Processor

THE ACCOUNTS PAYABLE PROCESSOR WILL SUPPORT DAILY AP OPERATIONS ACROSS BOTH PO A...

Location

United States , Houston

Salary:

60.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

LAWSON (INFOR) EXPERIENCE REQUIRED
EXCEL PROFICIENCY REQUIRED
DEMONSTRATED ABILITY TO MANAGE HIGH-VOLUME INVOICE PROCESSING
HEALTHCARE AP EXPERIENCE REQUIRED FOR PO-SIDE ROLES
HEALTHCARE EXPERIENCE NOT REQUIRED FOR NON-PO ROLE
STRONG CUSTOMER SERVICE AND VENDOR COMMUNICATION SKILLS
BACHELOR’S DEGREE PREFERRED OR EQUIVALENT WORK EXPERIENCE

Job Responsibility

PROCESS AND VALIDATE PO-BASED INVOICES WITHIN LAWSON
OWN THE 3-WAY MATCH (PO, RECEIVING, INVOICE)
RESEARCH AND RESOLVE PRICE DISCREPANCIES, MISSING RECEIPTS, AND VENDOR ISSUES
PARTNER CLOSELY WITH SUPPLY CHAIN / MATERIALS MANAGEMENT TO RECONCILE EXCEPTIONS
MANAGE VENDOR INQUIRY MAILBOXES AND COMMUNICATION
HANDLE VENDOR DISCUSSIONS ON REBATES, DISCOUNTS, AND PAYMENT TERMS (NET 1–15)
UTILIZE GHX PORTAL FOR EDI ELECTRONIC INVOICE PROCESSING
PROVIDE MENTORSHIP TO JUNIOR PROCESSORS AND SUPPORT CONTINUOUS IMPROVEMENT
MANAGE EXPENSE REPORTS, ELECTRONIC PAYMENTS, AND NON-PO INVOICE PROCESSING
PROCESS REIMBURSEMENTS THROUGH INFOR XM

What we offer

competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage
401k plan that includes a company match and is fully vested after you become eligible
paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching

New

Accounting Clerk

We are looking for a detail-oriented Accounting Clerk to join our team in Bakers...

Location

United States , Bakersfield

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Minimum of 3 years of experience in accounting or a related role
Proficiency in accounts receivable (AR) and accounts payable (AP) processes
Strong knowledge of QuickBooks and other accounting software
Exceptional attention to detail and accuracy in data entry
Ability to process invoices efficiently and with precision
Solid understanding of journal entries and bank reconciliations
Effective organizational and time management skills
Associate degree in accounting, business, or a related field preferred

Job Responsibility

Process accounts receivable transactions, including invoicing and payment tracking
Handle occasional accounts payable duties, ensuring accurate and timely payments
Maintain and update accounting databases to ensure data integrity
Record journal entries and assist with general ledger maintenance
Reconcile cash receipts and bank accounts to ensure financial accuracy
Review and process invoices, verifying details for completeness and accuracy
Perform data entry tasks to support accounting operations
Collaborate with team members to ensure seamless financial workflows
Utilize QuickBooks for managing and tracking financial activities

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

New

Cook

Hartwell Lodge Care Home in Fareham is looking for an experienced Cook or Chef t...

Location

United Kingdom , Fareham

Salary:

12.72 GBP / Hour

Buckland Care

Expiration Date

Until further notice

Requirements

Several years of experience in hospitality/catering is required
Level 2 Food & Hygiene is required
A City & Guilds Catering qualification would be ideal but is not a requirement
Passionate about food, local produce and fresh ingredients
Good level of English
A good team player
Excellent time management skills
Prioritising resident and relative needs and offering personalised menus when required
Honest and kind person who can work under pressure
Previous experience in a care home is beneficial

Job Responsibility

Work to create inspiring mealtimes for residents at the home, catering to all preferences and dietary requirements
Enjoy interacting and communicating with the elderly as there will be regular contact with our residents
Have up to date knowledge of food health and hygiene
Knowledge on fortified diets and soft diets, but we can train you on this if need be

New

Occupational Therapist

Inabia is seeking an experienced Occupational Therapist to join its Rehab Therap...

Location

United States , Robert Lee

Salary:

Not provided

Inabia Solutions & Consulting

Expiration Date

Until further notice

Requirements

Active Texas Occupational Therapist license (required)
SNF experience preferred
No new graduates (experience required)
Strong documentation, communication, and patient-care skills

Job Responsibility

Evaluate patients’ functional abilities related to ADLs, mobility, cognition, and safety
Develop and implement individualized occupational therapy treatment plans
Provide skilled therapy services in accordance with physician orders and facility protocols
Educate patients and caregivers on adaptive techniques and equipment
Monitor patient progress and adjust plans of care as needed
Document evaluations, daily treatments, and discharge summaries accurately and timely
Collaborate with interdisciplinary team members to support patient outcomes

What we offer

Consistent weekday daytime schedule
Manageable patient caseload
Opportunity to work in a focused SNF rehab environment
Supportive interdisciplinary team

Fulltime

Senior Director – Global Regulatory Strategy Biologics

NonStop Consulting

Location:
Switzerland , Geneva

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

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