Referso Jobs

Business Systems and Validation Analyst II

Thermo Fisher Scientific · Posted Nov 9, 2026

Open

Zaventem, Flanders, Belgium

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Business Systems and Validation Analyst II

Thermo Fisher Scientific · Posted Nov 9, 2026

Open

Zaventem, Flanders, Belgium

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Scientist, Process Development

Gilead Sciences · Posted Nov 7, 2026

Open

Foster City, California, United States
$147K–$190K per year
6+ years

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Compensation

The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Responsibilities

Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi-specifics, and novel modalities.
Lead and/or support entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA filing, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.
Lead and/or support technology transfer, person-in-plant, and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group.
Design experiments and perform hands‑on cell culture operations in shake flasks, ambr15, ambr250, bench‑scale bioreactors, and novel cell culture platforms.
Provide support to pilot plant operation for up to 500 L.

Requirements

Bachelor's Degree
Master's Degree
PhD/PharmD

Skills

cell culture process development

Senior R Programmer/ Shiny Developer

Premier Research · Posted Sep 9, 2026

Open

Argentina
Senior
5+ years

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Designs, develops, tests, and maintains interactive R Shiny applications that support clinical trial activities, ensuring they are scalable and performant for large-scale clinical data analysis.

Responsibilities

Designs, develops, tests, and maintains interactive R Shiny applications that support clinical trial activities.
Creates user-friendly applications for statistical review, data exploration, quality control, and reporting.
Develops reusable Shiny modules and application frameworks to promote consistency and efficiency.
Optimizes application performance, scalability, and usability.
Develops reusable programming utilities using R, SAS, and Python.

Requirements

Bachelor's degree in Statistics, Computer Science, Mathematics, Data Science, or a related quantitative field
Master's preferred
Nice to have: Open-source community participation

Skills

R RShiny RStudio SAS Python clinical data analysis

HFUE Associate Director

Sanofi · Posted Nov 6, 2026

Open

Morristown, New Jersey, United States
$149K–$215K per year
10+ years

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Lead HF/UE strategy and execution across multiple programs and business units, driving user‑centric design and ensuring product safety and effectiveness across Sanofi's product portfolio.

Compensation

The salary range for this position is: $148.500,00 - $214.500,00

Responsibilities

Lead HF/UE strategy and execution across multiple programs and business units, ensuring rigorous, fit‑for‑purpose application of human factors engineering from early engagement through LCM
Drive user‑centered design processes across the product portfolio, ensuring user needs, use requirements, and UI design decisions are grounded in robust research and risk‑based thinking
Shape and continuously improve HF/UE processes, methodologies, tools, and templates to advance team capabilities and ensure alignment with current FDA expectations and global standards
Lead complex generative, formative, and summative HF/UE studies, including study design, protocol development, execution, data analysis, and reporting
Conduct and oversee use‑related risk analysis (URRA), task analysis, known use problems analysis, and use‑related risk control evaluation across assigned programs

Requirements

Bachelor's in Engineering
Human factors Psychology
Industrial Design
Life Sciences
Nice to have: Master's degree in Engineering

Skills

Associate Manager - CMC Regulatory

Elanco · Posted Nov 5, 2026

Open

Bangalore, India
Associate
3–5 years

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Lead CMC regulatory strategy and submission preparation for animal drug products across global regions.

Responsibilities

Oversee end-to-end life cycle management of small and large molecules, complex dosage forms, sterile preparations, and biotechnology-derived products
Design and develop CMC regulatory strategy for marketed products
Maintain collaboration with R&D, Quality, Manufacturing and global regulatory partners
Lead CMC submission preparation for multiple geographies
Communicate regulatory strategy and key issues to interdisciplinary project teams

Requirements

Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences)
Nice to have: Experience with CMC registrations in US, Europe, or Rest of the World
Nice to have: Experience managing multiple pharmaceutical dosage forms
Nice to have: Strong communication skills
Nice to have: Decision making

Skills

Regulatory strategy CMC regulatory FDA/CVM guidelines EMA guidelines

Associate - Regulatory Affairs

ClinChoice · Posted Nov 2, 2026

Open

Chennai, Tamil Nadu, India
On-site
Full-time · Associate
0–2 years

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Support regulatory data management and compliance with ISO Identification of Medicinal Products (IDMP) standards, manage EMA Article 57 database, ensure data accuracy, and align regulatory submissions with IDMP requirements.

Responsibilities

Manage and maintain regulatory data within the EMA Article 57 database
Ensure compliance with IDMP standards and evolving regulatory requirements
Support the electronic submission of regulatory data to EMA
Collaborate with cross-functional teams to ensure data consistency and integrity
Assist in mapping and transformation of medicinal product data to meet IDMP standards

Requirements

Bachelor’s/Master’s degree in Life Sciences
Bachelor’s/Master’s degree in Pharmacy
Bachelor’s/Master’s degree in Regulatory Affairs
Nice to have: xEVMPD
Nice to have: pharmaceutical regulatory affairs

Skills

A57 database management IDMP compliance Regulatory Information Management Systems (RIMS)SPOR data management EU regulatory requirements

Senior Scientist II – Analytical Chemistry

Pharmaron · Posted Nov 4, 2026

Open

Coventry, Rhode Island, United States
Senior
$90K–$130K per year
1–10 years

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Senior Scientist II – Analytical Chemistry

Compensation

Salary Range: $90k - $130k

Responsibilities

Support analytical method validation, verification, and transfer activities within the QC laboratory.
Troubleshoot complex analytical challenges related to API characterization and GMP testing.
Review analytical data, laboratory notebooks, and instrument qualification documentation to ensure scientific accuracy and regulatory compliance.
Lead or support laboratory investigations, deviations, and root cause analyses.
Maintain laboratory equipment and serve as system owner for analytical instrumentation, including qualification and maintenance activities.

Requirements

Ph.D. in Chemistry
MS in Chemistry
BS in Chemistry
Nice to have: mentoring
Nice to have: supervising laboratory personnel

Skills

HPLC UPLC GC FTIR UV

Business Systems and Validation Analyst II

Business Systems and Validation Analyst II

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Scientist, Process Development

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Senior R Programmer/ Shiny Developer

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HFUE Associate Director

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Associate Manager - CMC Regulatory

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Associate - Regulatory Affairs

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Senior Scientist II – Analytical Chemistry

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EMA guidelines jobs

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