Senior Regulatory Affairs Consultant (CMC)

Scendea is seeking a highly motivated individual to join our global team as a full-time Senior Consultant (CMC). This is a hybrid position, affiliated to either our Bishop's Stortford (UK), Brisbane (AUS) or Washington, D.C. Office (USA), with a requirement to work in the office a minimum of one day per month. This is an excellent opportunity to progress your career at a rapidly growing product development, regulatory, and compliance consultant group.

You will have the opportunity to play a key role in the development and mentoring of colleagues whilst providing high-quality regulatory technical advice and product development strategies for clients.

• Provide strategic, technical and regulatory advice/services to clients with a special interest in Chemistry, Manufacturing, and Controls (CMC) development of human medicinal products.
• Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
• Provide innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
• Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs according to area of expertise.
• Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
• Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
• Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets.
• Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
• Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.
• Line manage, train, and mentor members of the Scendea Operational team, including providing technical leadership.

• A high scientific calibre with a relevant science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life/physical science focused MSc or preferably a PhD).
• Authoring of CMC sections of regulatory documentation is required.
• MAA/BLA experience is highly desirable.
• A minimum of five years of drug development experience.
• A minimum of five years of regulatory experience, working with either FDA, EMA, and/or MHRA submissions, including meetings/negotiation.
• Regulatory experience may include time within a National Competent Authority.
• Demonstrated experience with a broad range of products, including recombinant proteins and peptides (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, advanced therapy medicinal products (tissue, cell and gene therapy), RNA or DNA based products, live biotherapeutics and small molecule NCE and/or generic chemical entities.
• Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.
• Proven ability and willingness to lead a team and deliver education and training in chosen field, both internally, and at scientific conference presentations.
• Exemplary organisational and time management skills with a high level of attention to detail, and the proven ability to work both proactively and autonomously.
• High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs.
• Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.

Scendea is an international product development, regulatory, and compliance consulting group delivering market-leading scientific expertise.