Regulatory Consultant, CMC Biopharma

Ecolab

Biopharma Regulatory Consultant providing consulting and support for Ecolab's chromatography resin solutions. Collaborating with customers to optimize purification and regulatory processes across Europe.

Posted 7/29/2026full-timeCardiff • 🇬🇧 United KingdomMid-LevelSenior💰 €7,425 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in downstream purification processes, particularly chromatography applications, and possesses strong knowledge of GMP, quality systems, and regulatory compliance in Biopharma manufacturing. Capable of delivering technical consulting, training, and presentations while effectively engaging with stakeholders to drive process improvements and customer satisfaction.

Highest-signal resume keywords

Downstream Purification ProcessesChromatography ApplicationsGMP ComplianceTechnical Training DeliveryRegulatory Change Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Biopharma ManufacturingProcess DevelopmentPurification SciencesTechnical ServiceQuality SystemsValidation PrinciplesExperimental DesignRisk AssessmentData AnalysisTroubleshooting

Soft Skills

Excellent Communication SkillsAnalytical ThinkingCustomer DiscoveryProblem SolvingStakeholder Influencing

Industry Keywords

Life SciencesBiochemistryBiotechnologyChemical EngineeringBioprocess EngineeringRegulatory AffairsChange ControlValidationMSATCDMO

About the role

Key responsibilities & impact

Provide technical consulting services that leverage Ecolab’s expertise in chromatography resin performance, downstream purification, and regulatory change management to help commercial teams understand customer needs and increase account revenue.
Act as a pre-sales and customer-facing technical expert for Biopharma opportunities, especially where resin conversion, process optimization, supply security, or regulatory change complexity are key decision drivers.
Work alongside customers at their facilities to identify opportunities to improve purification performance, product quality, operational efficiency, resin lifetime, and risk mitigation while maintaining regulatory compliance.
Support or manage customer resin evaluation, comparability, and validation activities by advising on methodology, experimental design, small-scale model qualification, accelerated resin aging studies, and regulatory filing strategy.
Support customer change control processes by contributing technical documentation, risk assessments, validation rationale, training material, and regulatory change packages in a timely and accurate manner.
Build trusted relationships with technical and regulatory decision makers, including Process Development, MSAT, Manufacturing, Quality, Regulatory Affairs, Procurement, and CDMO stakeholders.
Use data, customer insight, and business acumen to articulate the value of Ecolab purification solutions, including total cost of ownership, process robustness, supply continuity, and regulatory change de-risking.
Serve as an internal and external subject matter expert by presenting at customer meetings, technical forums, industry events, webinars, and conferences to strengthen Ecolab’s credibility in Biopharma purification.
Support product, service, and digital innovation by capturing customer pain points, identifying compelling events such as supply disruptions or patent cliffs, and partnering with marketing, R&D, regulatory, and commercial teams to develop scalable Biopharma offerings.

Requirements

What you’ll need

Bachelor of Science degree or equivalent in Life Sciences, Biochemistry, Biotechnology, Chemical Engineering, Bioprocess Engineering, or a related discipline.
Experience in Biopharma manufacturing, process development, MSAT, purification sciences, technical service, quality, regulatory affairs, or a related customer-facing technical role.
Strong understanding of downstream purification processes, especially chromatography applications used in biologics manufacturing.
Experience troubleshooting technical challenges, supporting investigations, evaluating process performance data, and developing practical corrective or improvement actions.
Experience designing and delivering technical training or customer-facing technical presentations.
Strong understanding of GMP, quality systems, change control, validation principles, and regulatory expectations for Biopharma manufacturing.
Excellent oral and written communication skills, analytical thinking, customer discovery, problem solving, and stakeholder influencing skills.
Ability to travel 50%+ of time in region, potentially at short notice.
Clean driver’s license and ability to apply for travel visas.
Fluent in English.

Benefits

Comp & perks

Health insurance
Pension scheme
Paid time off
Professional development opportunities
Flexible working hours