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Senior Regulatory CMC Consultant - Biologics at RBW Consulting
london, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 20 year(s)
Laboratory Technician at RBW Consulting
England, London - England, United Kingdom - Full Time
Skills Needed
N/A
Senior Legal Officer at CRA Consulting
Germany, Hamburg, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 10 year(s)
Supply Chain at CO3 Consulting
berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
QC Analyst at RBW Consulting
England, Louisiana, United Kingdom - Full Time
Skills Needed
N/A
Service Coordinator at Roc Consulting
australia, New South Wales, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Backend Software Engineer at FAR Consulting
Canada, Alberta, Canada - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Legal Administrator/ Paralegal at CRA Consulting
Germany, Hamburg, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 10 year(s)
Human Resource Manager at ESE Consulting
Victoria, Victoria, Australia - Full Time
Skills Needed
N/A
Electrical Engineer at ETS Consulting
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 9 year(s)
Tax Specialist at Roc Consulting
Sydney, Syddanmark, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 7 year(s)
Risk Manager at CRA Consulting
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
Clinical Research Associate at RBW Consulting
England, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Cost Controller at MPH Consulting
Abu Dhabi, Abu Dhabi, United Arab Emirates - Full Time
Skills Needed
N/A
Experience Required
Minimum 14 year(s)
Quality Assurance Officer at RBW Consulting
England, London - England, United Kingdom - Full Time
Skills Needed
N/A
Pharmacovigilance Manager at RBW Consulting
London, Queensland, United Kingdom - Full Time
Skills Needed
N/A
Quality Control Chemist at RBW Consulting
Dorset, Dorset - England, United Kingdom - Full Time
Skills Needed
N/A
Quality Supervisor at RBW Consulting
london, Herefordshire - England, United Kingdom - Full Time
Skills Needed
N/A
Senior Operations Project Manager at TGC Consulting
BERLIN, Berlin, Germany - Full Time
Skills Needed
N/A
Solution Architect at QIX Consulting
Sydney, Australian Capital Territory, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Senior Regulatory CMC Consultant - Biologics at RBW Consulting
london, London - England, United Kingdom -
Full Time

Start Date

Immediate

Expiry Date

04 Jan, 27

Salary

75000.0

Posted On

06 Oct, 26

Experience

20 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical & Personal Care Products

Description

About the job


Senior Regulatory CMC Consultant - Biologics / ADC ProgrammesGlobal MAA & BLA Strategy | Regulatory CMC Leadership | Contract

We're supporting a global pharmaceutical organisation as they strengthen Regulatory CMC leadership across a high-profile biologic Antibody-Drug Conjugate (ADC) programme approaching major regulatory milestones.This opportunity will suit an experienced Regulatory CMC professional who combines strategic leadership with hands-on execution and has a proven track record leading Module 3 activities for biologic MAA and/or BLA submissions. Operating within an international matrix environment, you will partner closely with Regulatory Affairs, CMC Development, Quality, Manufacturing and Technical Writing teams to drive global registration readiness and submission success.

  • The OpportunityLead the global Regulatory CMC strategy for a late-stage biologic ADC programme intended for worldwide registration.
  • Provide strategic guidance and oversight for global MAA and BLA preparation, submission and review activities.
  • Drive alignment between CMC development activities, regulatory strategy and wider programme objectives.
  • Lead cross-functional regulatory planning, governance and risk management across multiple internal and external stakeholders.
  • Act as a senior Regulatory CMC advisor supporting health authority interactions across major global markets.


  • Key ResponsibilitiesDevelop and execute global Regulatory CMC strategies for complex biologic products.
  • Lead CMC aspects of MAA and/or BLA submissions, ensuring quality, compliance and timely delivery.
  • Review and finalise Module 3 documentation, ensuring scientific robustness and regulatory suitability.
  • Lead preparation for FDA, EMA and other global health authority interactions, including briefing documents and regulatory responses.
  • Provide strategic input on regulatory positioning, risk mitigation and agency engagement plans.
  • Coordinate cross-functional activities across Regulatory Affairs, CMC, Technical Operations, Quality and Manufacturing.
  • Support responses to health authority questions, deficiency letters and post-submission activities.
  • Ensure compliance with evolving global regulations, guidelines and CMC expectations for biologics and ADC products.
  • Drive stakeholder alignment and delivery across a complex global matrix structure.


  • Consultant ProfileWe are particularly interested in Regulatory CMC professionals who can demonstrate:Extensive Regulatory Affairs CMC experience within biotechnology and/or pharmaceutical environments.
  • Proven hands-on leadership of Module 3 activities supporting biologic MAA and/or BLA submissions.
  • Strong expertise across biologics, including complex products and advanced therapeutics.
  • Experience developing and implementing global Regulatory CMC strategies through late-stage development and registration.
  • Deep understanding of FDA, EMA, ICH and global CMC regulatory requirements.
  • Experience preparing and supporting health authority interactions, scientific advice meetings and regulatory negotiations.
  • Strong stakeholder management and matrix leadership capability.
  • The ability to operate strategically whilst remaining hands-on when required.
  • Excellent communication, collaboration and problem-solving skills.


Cmc, regulatory, affairs, ADC, antibody, drug, conjugate, biologics, large, molecule, submission, BLA, MAA, consultant, interim, freelance

How To Apply:

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Responsibilities

About the job


Senior Regulatory CMC Consultant - Biologics / ADC ProgrammesGlobal MAA & BLA Strategy | Regulatory CMC Leadership | Contract

We're supporting a global pharmaceutical organisation as they strengthen Regulatory CMC leadership across a high-profile biologic Antibody-Drug Conjugate (ADC) programme approaching major regulatory milestones.This opportunity will suit an experienced Regulatory CMC professional who combines strategic leadership with hands-on execution and has a proven track record leading Module 3 activities for biologic MAA and/or BLA submissions. Operating within an international matrix environment, you will partner closely with Regulatory Affairs, CMC Development, Quality, Manufacturing and Technical Writing teams to drive global registration readiness and submission success.

  • The OpportunityLead the global Regulatory CMC strategy for a late-stage biologic ADC programme intended for worldwide registration.
  • Provide strategic guidance and oversight for global MAA and BLA preparation, submission and review activities.
  • Drive alignment between CMC development activities, regulatory strategy and wider programme objectives.
  • Lead cross-functional regulatory planning, governance and risk management across multiple internal and external stakeholders.
  • Act as a senior Regulatory CMC advisor supporting health authority interactions across major global markets.


  • Key ResponsibilitiesDevelop and execute global Regulatory CMC strategies for complex biologic products.
  • Lead CMC aspects of MAA and/or BLA submissions, ensuring quality, compliance and timely delivery.
  • Review and finalise Module 3 documentation, ensuring scientific robustness and regulatory suitability.
  • Lead preparation for FDA, EMA and other global health authority interactions, including briefing documents and regulatory responses.
  • Provide strategic input on regulatory positioning, risk mitigation and agency engagement plans.
  • Coordinate cross-functional activities across Regulatory Affairs, CMC, Technical Operations, Quality and Manufacturing.
  • Support responses to health authority questions, deficiency letters and post-submission activities.
  • Ensure compliance with evolving global regulations, guidelines and CMC expectations for biologics and ADC products.
  • Drive stakeholder alignment and delivery across a complex global matrix structure.


  • Consultant ProfileWe are particularly interested in Regulatory CMC professionals who can demonstrate:Extensive Regulatory Affairs CMC experience within biotechnology and/or pharmaceutical environments.
  • Proven hands-on leadership of Module 3 activities supporting biologic MAA and/or BLA submissions.
  • Strong expertise across biologics, including complex products and advanced therapeutics.
  • Experience developing and implementing global Regulatory CMC strategies through late-stage development and registration.
  • Deep understanding of FDA, EMA, ICH and global CMC regulatory requirements.
  • Experience preparing and supporting health authority interactions, scientific advice meetings and regulatory negotiations.
  • Strong stakeholder management and matrix leadership capability.
  • The ability to operate strategically whilst remaining hands-on when required.
  • Excellent communication, collaboration and problem-solving skills.


Cmc, regulatory, affairs, ADC, antibody, drug, conjugate, biologics, large, molecule, submission, BLA, MAA, consultant, interim, freelance
Senior Regulatory CMC Consultant - Biologics at RBW Consulting
london, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 20 year(s)
Laboratory Technician at RBW Consulting
England, London - England, United Kingdom - Full Time
Skills Needed
N/A
Senior Legal Officer at CRA Consulting
Germany, Hamburg, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 10 year(s)
Supply Chain at CO3 Consulting
berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
QC Analyst at RBW Consulting
England, Louisiana, United Kingdom - Full Time
Skills Needed
N/A
Service Coordinator at Roc Consulting
australia, New South Wales, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Backend Software Engineer at FAR Consulting
Canada, Alberta, Canada - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Legal Administrator/ Paralegal at CRA Consulting
Germany, Hamburg, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 10 year(s)
Human Resource Manager at ESE Consulting
Victoria, Victoria, Australia - Full Time
Skills Needed
N/A
Electrical Engineer at ETS Consulting
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 9 year(s)
Tax Specialist at Roc Consulting
Sydney, Syddanmark, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 7 year(s)
Risk Manager at CRA Consulting
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
Clinical Research Associate at RBW Consulting
England, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Cost Controller at MPH Consulting
Abu Dhabi, Abu Dhabi, United Arab Emirates - Full Time
Skills Needed
N/A
Experience Required
Minimum 14 year(s)
Quality Assurance Officer at RBW Consulting
England, London - England, United Kingdom - Full Time
Skills Needed
N/A
Pharmacovigilance Manager at RBW Consulting
London, Queensland, United Kingdom - Full Time
Skills Needed
N/A
Quality Control Chemist at RBW Consulting
Dorset, Dorset - England, United Kingdom - Full Time
Skills Needed
N/A
Quality Supervisor at RBW Consulting
london, Herefordshire - England, United Kingdom - Full Time
Skills Needed
N/A
Senior Operations Project Manager at TGC Consulting
BERLIN, Berlin, Germany - Full Time
Skills Needed
N/A
Solution Architect at QIX Consulting
Sydney, Australian Capital Territory, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)