Biotechnology Jobs

362 jobs for “Product Support Application Specialist”

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Ipsen

Director, Regulatory Affairs, Labelling

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  • London
  • Director · manages people

Lead global labelling strategy for assigned products across early and late-stage development, lifecycle management and marketed portfolios, serving as Therapeutic Area Lead. Drive core labelling documents including CCDS, USPI and EU PI, lead health authority negotiations, and shape a future USPI operating model while championing digitalisation and AI-enabled labelling solutions.

FDA · EMA · ICH

3 months ago
GSK logo

GSK · 10000+ people · Public

Head, Oncology Clinical Development - ADCs

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  • London
  • Hybrid · 2 days in office
  • US$242,250 – US$403,750 pa
  • Director · manages people

Accountable for end-to-end clinical development strategy for a multi-tumor oncology asset, spanning first-in-human through registrational trials, regulatory filing and initial market launch. Acts as senior clinical representative at governance forums and leads cross-functional, matrixed teams across research, precision medicine, medical affairs and commercial. Requires deep antibody-drug conjugate and global health authority experience.

2 weeks ago
GSK logo

GSK · 10000+ people · Public

Head, Oncology Clinical Development - ADCs

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  • USA - Pennsylvania - Upper Providence
  • Hybrid · 2 days in office
  • US$242,250 – US$403,750 pa
  • Director · manages people

Accountable for end-to-end clinical development strategy for an antibody-drug conjugate asset across multiple tumour types, from first-in-human through registrational trials and launch. Acts as senior clinical representative at governance forums and leads cross-functional, matrixed teams spanning research, precision medicine, medical affairs and commercial.

2 weeks ago

AstraZeneca · 10000+ people · Public

Regulatory Affairs Director

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  • Cambridge
  • On-site
  • Director · manages people
  • Permanent

Leads cross-functional teams on major EU regulatory submissions (MAA, CTR, IVDR, CTA), health authority interactions with the EMA and national bodies, label negotiations and approvals. Owns the EU engagement strategy, briefing documents and regulatory strategy for oncology programmes, mentoring the Global Regulatory Strategy Team. Distinct for its focus on late-stage oncology assets and European approval pathways.

MAA · CTA · CTR +2

2 weeks ago

AstraZeneca · 10000+ people · Public

Global Development Medical Director, Late Respiratory and Immunology Clinical Development

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  • Cambridge
  • Hybrid · 3 days in office
  • Director

Provides medical and scientific leadership across late-stage respiratory and immunology clinical programs, from Phase IIb to Phase IV. Involves designing, executing and interpreting pivotal trials, medical monitoring, regulatory document input and building relationships with external scientific experts in an international team.

Last month

IQVIA

Senior Clinical Supply Chain Manager (FSP)

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  • Reading
  • Senior

Embedded with a global pharmaceutical sponsor, you own end-to-end clinical supply strategy across complex trials: protocol interpretation, label text, demand forecasting, packaging, IRT setup, distribution and temperature-excursion management. You lead vendor oversight, risk assessments and budget tracking while advising study teams and client leadership.

IRT · RTSM · ERP +3

2 days ago
CSL logo

CSL · 10001+ people · Public

Associate Director, Biostatistics

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  • Maidenhead
  • Hybrid · 3 days in office
  • US$212,000 – US$251,000 pa
  • Director

Leads the full statistical contribution to a clinical development programme, defining statistical strategy for trial design, analysis and regulatory submissions, and representing Biostatistics in interactions with the FDA, EMA and PMDA. Also manages outsourcing to CROs/FSPs and contributes to governance and development-plan decisions across therapeutic areas.

SAS · R

Last week
CSL logo

CSL · 10001+ people · Public

Medical Evaluator - Global Case Management

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  • Maidenhead
  • Mid-level

Oversees vendor delivery of medical evaluations for individual case safety reports, applying medical and scientific judgment on causality, expectedness and seriousness. Trains Medical Evaluators, sets assessment frameworks and drives process improvements across Global Safety and Pharmacovigilance. Requires deep pharmacovigilance knowledge and cross-functional stakeholder work.

5 days ago

Mytos

Junior/Mid Software Engineer

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  • London
  • Hybrid · 2–3 days in office
  • Junior

Contribute across a full-stack cloud product and IoT devices that interface with hardware automating human cell production. Work spans TypeScript, React, GraphQL frontends and Node.js/PostgreSQL backends, with cross-disciplinary collaboration alongside hardware engineers and biologists, including testing on prototype machines in the lab.

React · TypeScript · GraphQL +7

20 months ago
Ellison Institute of Technology logo

Ellison Institute of Technology · 501–1000 people · Non-profit

Controlled Environment Lead - Plant Biology Institute

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  • Oxford
  • On-site
  • Lead · manages people
  • Permanent

Build and oversee plant growth and phenotyping facilities, ensuring controlled, reproducible environments in growth chambers and greenhouses. Hands-on player-coach role covering planting, irrigation, pollination, sampling and harvest, plus pest and pathogen management, GMO compliance and phenotype data capture. Also shapes field trial operations and future team hiring.

Controlled Environment Growth Chambers · Greenhouses

Last month

Johnson & Johnson Innovative Medicine

Oncology Global Regulatory Affairs Intern (EMEA)

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  • High Wycombe
  • Hybrid · 3 days in office
  • Entry level
  • Internship

A 12-week summer internship in EMEA Global Regulatory Affairs within the Oncology therapeutic area, working on a hybrid model with three days on site. Interns join a global matrixed team supporting clinical strategies and Phase I-III oncology studies, contributing to regulatory strategy, clinical trial applications and product registration activities, with a mentor, cross-functional team meetings and a research poster presented at a company-wide symposium.

Microsoft Outlook · Microsoft Excel · Microsoft PowerPoint +5

3 days ago
Ellison Institute of Technology logo

Ellison Institute of Technology · 501–1000 people · Non-profit

Scientist - Applications Team (Pathogen)

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  • Oxford
  • On-site
  • Entry level
  • Permanent

Hands-on laboratory role supporting microbiology, molecular biology, sample processing and sequencing within the Pathogen Applications Team. Involves receiving and tracking clinical samples, preparing microbial cultures, running qPCR and sequencing workflows, and maintaining QC and documentation. Suits an early-career scientist with practical lab experience in a diagnostic or high-throughput environment.

Sequencing · Oracle Cloud

Last month

Agilent

Expert R&D Scientist – Chromatography Materials

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  • Church Stretton
  • Senior

Technical lead role driving innovation in polymeric and silica particle technologies for chromatography, diagnostics and biopharma consumables. Involves independently designing and executing complex polymer synthesis, particle manufacture and surface functionalization, plus technology transfer from lab-scale prototypes to full production. Acts as internal consultant and escalation point for critical materials issues, mentors scientists and shapes long-term technology strategy.

3 weeks ago

Vertex Pharmaceuticals

Regulatory Affairs Fellow (12 months)

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  • London
  • Hybrid
  • Entry level
  • Temporary

A one-year PhD fellowship within an International Regulatory Affairs team, supporting development programs and marketed products. The fellow helps build and implement regulatory strategy, prepares and submits applications to local health authorities under supervision, and reviews regulatory intelligence to keep submissions compliant. Based at the London headquarters with hybrid or on-site working options.

Last week

Eurofins

Analytical Scientist

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  • Liverpool
  • On-site
  • Permanent

Perform routine, non-routine and stability testing on finished pharmaceutical products at a client site, using HPLC, Dissolution, Karl Fischer and UV techniques. The role also covers technology transfers, analytical validation, GMP data review and OOS investigations, working within a managed services team embedded at the client's facility.

HPLC · Dissolution · Karl Fischer +4

3 weeks ago

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