RBW Consulting
Senior Regulatory CMC Consultant
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Senior Regulatory CMC Consultant (Drug Substance/ ADC)
6-Month Contract (Renewable - ongoing) | Remote | Global Regulatory Strategy
Are you a seasoned Regulatory CMC professional with deep expertise in drug substance development and a proven track record supporting global marketing authorisation submissions? We are supporting an innovative global biopharmaceutical organisation seeking a Senior Regulatory CMC Consultant to provide strategic leadership for the regulatory drug substance activities associated with a high-profile development programme. This role will have a particular focus on Antibody Drug Conjugates (ADCs), making prior ADC experience desirable but not essential.
The Opportunity
As a senior member of the Regulatory CMC team, you will be responsible for defining and driving the global regulatory strategy for the drug substance component of the programme, working closely with cross-functional teams across Europe and the United States. This is a highly visible position requiring both technical expertise and strategic regulatory leadership as the organisation prepares for key global submissions.
Key Responsibilities
- Lead the Regulatory CMC strategy for the drug substance element of a complex biologics programme, with a particular focus on ADC linker-payload development.
- Provide strategic guidance for upcoming global Marketing Authorisation Applications, including submissions to the FDA and EMA.
- Act as the Regulatory CMC subject matter expert for drug substance development activities.
- Lead the preparation, review and delivery of Module 3 drug substance documentation.
- Ensure compliance with current ICH, FDA and EMA guidelines and expectations.
- Partner with CMC, analytical development, manufacturing, quality and regulatory colleagues to drive submission readiness.
- Assess regulatory risks and develop mitigation strategies to support programme timelines.
- Provide scientific and regulatory leadership within cross-functional project teams.
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About You
To be successful in this role, you will bring:
- Approximately 10+ years' experience within Regulatory Affairs.
- Strong experience supporting drug substance development programmes.
- Proven track record leading the CMC drug substance aspects of global Marketing Authorisation submissions.
- Excellent understanding of regulatory requirements relating to Module 3 drug substance sections.
- Extensive knowledge of ICH, FDA and EMA regulations and guidance.
- Strong analytical and scientific expertise relating to drug substance development.
- Outstanding stakeholder management and cross-functional collaboration skills.
- Ability to influence and operate effectively within complex, fast-paced environments.
- Excellent critical thinking, problem-solving and strategic planning abilities.
- Fluent English communication skills, both written and verbal.
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Highly Desirable
- Direct experience with Antibody Drug Conjugates (ADCs).
- Experience supporting the regulatory strategy for linker-payload development.
- Exposure to biologics and advanced therapeutic products.
Contract Details
- Start: ASAP
- Duration: Initial 6-month contract with strong likelihood of extension
- Location: Remote
- Requirement: Must be able to work within a time zone that enables collaboration with both European and US-based teams.
This is an excellent opportunity for an experienced Regulatory CMC consultant looking to play a key role in a globally significant programme with a strong focus on drug substance strategy and innovative ADC development!
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