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Principal Consultant (CMC), Watford, Hertfordshire

Client:

Location:

Watford, Hertfordshire, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

Job Views:

8

Posted:

06.06.2025

Expiry Date:

21.07.2025

Job 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 either our UK, Netherlands, Australia, or US offices, with a requirement to work in the office at least one day per month.

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, focusing 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, including 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 current and future projects, contracts, or new business opportunities.
• Support business development through sales/marketing efforts and generate additional business from existing clients.
• Manage, train, and mentor team members, providing technical leadership.

Skills and Experience

• Relevant scientific degree (BSc, MSc, or PhD) in biomedical or related field.
• Extensive experience (minimum ten years) in CMC strategy, development, and regulatory compliance.
• Expertise in CMC-related regulatory requirements (FDA, EMA, ICH guidelines).
• Experience with FDA, MHRA, EMA submissions, meetings, and negotiations.
• Experience with a broad range of products, including biologics, vaccines, biosimilars, advanced therapies, and nucleic acid-based products.
• Proven ability to plan strategically from early development to marketing authorization.
• Experience in consultancy and business development.
• Leadership skills with the ability to train and mentor teams.
• Excellent organizational, communication, and presentation skills.
• Willingness to travel and work flexible hours.

The Company

Scendea is an international regulatory consulting group dedicated to advancing healthcare innovation through scientific and regulatory expertise. We aim to streamline product development, reduce time-to-market, and lower costs. Our team of over 50 staff is based across the UK, Netherlands, Australia, and the US, experiencing significant growth.

We are committed to societal impact, environmental responsibility, and fostering an inclusive, transparent, and ethical work culture.

As a Scendea Employee

We value motivated, passionate, and trustworthy individuals who are committed to excellence and customer satisfaction. Our employees are encouraged to inspire and lead, contributing to our success and growth.

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.