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Principal Consultant (CMC), Bishop's Stortford
Location: Bishop's Stortford, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Views: 8Posted: 06.06.2025Expiry Date: 21.07.2025Job Description:
The Role
Scendea is seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). This is a hybrid position, affiliated with our UK, Netherlands, Australia, or US offices, requiring a minimum of one day per month in the office.
This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will play a key role in staff development and mentoring while providing high-quality regulatory technical advice and product development strategies for clients.
Role Requirements
- Provide strategic, technical, and regulatory advice/services to clients with a focus on CMC development of human medicinal products.
- Develop innovative drug development plans, data gap analyses, and international regulatory strategies for complex products within a changing regulatory environment.
- Contribute to the technical authorship and review of regulatory documents such as Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, and more.
- Lead multi-jurisdiction programs and deliver consulting services within your expertise.
- Represent clients in regulatory agency interactions and provide solutions to agency objections.
- Ensure project goals are met within timelines and budgets.
- Lead meetings with stakeholders on projects, contracts, or new business opportunities.
- Support business development efforts and generate additional client business.
- Manage, train, and mentor team members, providing technical leadership.
Skills and Experience
- A relevant science-focused BSc, higher degree (MSc or PhD) in biomedical or related fields.
- Extensive experience in CMC strategy and at least ten years in CMC development and regulatory compliance.
- Expertise in CMC-related regulatory requirements, including FDA, EMA, ICH guidelines.
- Experience with FDA, MHRA, and EMA submissions, including meetings and negotiations.
- Experience with various products, including biologics, vaccines, biosimilars, advanced therapy medicinal products, RNA/DNA products, and live biotherapeutics.
- Proven ability to plan and deliver strategic regulatory solutions from early development to marketing authorization.
- Experience in consultancy and business development, with strong communication skills.
- Leadership and mentoring skills, with the ability to work proactively and independently.
- Excellent organizational, time management, and communication skills in English, with proficiency in MS Office.
- Willingness to work flexible hours and travel as needed.
The Company
Scendea is an international regulatory consulting group dedicated to healthcare innovation. We focus on streamlining product development, reducing time-to-market, and minimizing costs. Our team of over 50 staff across the UK, Netherlands, Australia, and the US is growing, and we are committed to environmental sustainability and an inclusive work culture.
As a Scendea Employee
We value motivated individuals with passion, integrity, and customer focus. You should inspire trust and confidence, motivate others, and always prioritize customer satisfaction.
Eligibility & Conditions
Applicants must reside and be eligible to work in the UK, Netherlands, US, or Australia without sponsorship. The closing date for applications is Monday, 16 June 2025, with notifications by Friday, 20 June 2025.
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