Scendea
Principal Consultant (CMC Small Molecules) UK
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Scendea: Principal Consultant (CMC, Small Molecule Expertise) – Hybrid Role
Principal Consultant (CMC, Small Molecule) Hybrid (UK or Australia-based, minimum 1 day/office per month)
About the Role Scendea is seeking a highly motivated Principal Consultant with a proven track record in CMC for small molecule drug development. Ideal for a scientific leader to provide strategic, technical, and regulatory advice, mentor team members, and deliver high-level solutions in complex pharmaceutical development.
This executive consultancy role offers:
- Career progression at a fast-growing Regulatory Consultancy
- Regulatory and product development strategy expertise
- ** Leadership and mentoring** opportunities
- Global influence with hybrid flexibility
Key Responsibilities
Provide strategic, technical, and regulatory expertise in:
- CMC development for small molecule pharmaceuticals (human medicinal products)
- Innovative drug development plans, data gap analyses, and multijurisdictional regulatory strategies
- Technical authorship/review of critical regulatory documents:
- Regulatory Strategy Plans
- Drug Development & Clinical Trial Applications (Pre-IND, IND)
- Scientific Advice & Meeting Briefing Documents
- Marketing Authorisation Applications (MAA), New Drug Applications (NDA), Biologic Licence Applications (BLA), DMFs
- Lead complex projects, including multijurisdictional initiatives, ensuring timely delivery and budget adherence
Regulatory Liaison & Client Advocacy
- Represent clients during regulatory agency meetings; resolve objection responses.
- Collaborate with cross-functional stakeholders (internal/external) on project needs.
Business Development & Talent Growth
- Engage with client introductions, driving revenue expansion.
- Line-manage, train, and mentor operational teams, supporting Scendea’s transfer of expertise.
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Key Requirements
Professional Experience
- Minimum 10 years in CMC development for small molecule New Chemical Entities (NCE) or generic chemicals.
- Extensive regulatory experience (FDA/MHRA/EMA/TGA) with submissions, negotiations, and meetings.
- Preference if experience covers:
- Biologics (antibodies, vaccines, biosimilars)
- Advanced Therapy Medicinal Products (ATMPs) including cell/gene therapy
- RNA/DNA-based therapies, live biotherapeutics
Technical & Strategic Expertise
- Proven ability to deliver end-to-end regulatory strategy from early-stage development → MA.
- Expertise in *ICH guidelines, GMP compliance, and global CMC requirements.
- Experience in operational/consultancy environments with a client-facing, service-oriented mindset.
- Curated knowledge of dosage forms (oral, parenteral, inhaled, ointments).
- Demonstrable creative problem-solving for scientifically-driven regulatory gaps.
Professional & Soft Skills
- A high-quality science background (BSc + relevant MSc/PhD in biomedical/physical sciences).
- Executive communication skills:
- Fluent verbal presentation (stakeholder engagement, client propositions)
- Technical writing (expert-level drafting of regulatory impact).
- Established mentoring abilities including internal team leadership and external conference presentations.
- Proactiveness with exceptional time management and attention to detail.
- Cloud computer access + MS Office proficiency.
Work Style Compliance
- Willingness to flexible hours and short-notice travel (domestic/international).
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The Scendea Difference
We are a broadly driven Regulatory Consultancy, accelerating drug development by:
- Reducing time-to-market at every technological and business facet.
- Global reach with 50+ employees across US, UK, Netherlands, and Australia.
- Sustainability mission—channelling expertise toward healthcare innovation with minimal environmental impact.
- Inclusive culture: transparent decision-making; employees active in key engagements.
- Shared ownership: as part of an Employee Ownership Trust.
Dedication to Client Relations
At Scendea, we place the customer at the heart of every element—that’s why we invest in transparent collaboration, ethical partnerships, and individual talent growth. Thriving as a team requires:
Commitment to excellence
- Trustworthiness, dynamic interpersonal skills.
- Customer-first frameworks underpinned by legal integrity.
Resourceful problem-solving
- Pioneering thinking for ultimate patient-centric solutions.
Career & Growth Benefits
- Salary: Market-leading remuneration.
- Incentives:
- 26 days holiday (+ discretionary public/employee-based leave).
- 5% employer-sponsored pension.
- Employee Assistance Programme.
- Employee Ownership Trust Scheme (profit-sharing).
- Joining entitlements:
- Regulatory training + generous career development support.
- Private healthcare insurance.
- Opportunity to lead thinking in specialty CMC domains during real-world collaborations.
Additional Conditions
Residency requirement: Eligible to work full-time in the UK without sponsorship nexus or impending need.
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