At a Glance
- Tasks: Provide strategic regulatory advice and lead projects in small molecule drug development.
- Company: Join Scendea, a global leader in regulatory consultancy with a collaborative culture.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic environment with excellent career progression and international exposure.
- Why this job: Make a real impact in the pharmaceutical industry while mentoring future talent.
- Qualifications: PhD or MSc in biomedical field and extensive CMC experience required.
The predicted salary is between 63000 - 77000 £ per year.
Scendea is seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC, small molecules experience). The ideal candidate will have a proven track record in CMC for small molecule drug development, with expertise in process development, scale-up, regulatory submissions, and the pre-approval life cycle management of small molecule products. This is a hybrid position, affiliated to either of our UK or Australia offices, 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 Regulatory Consultancy.
You will have the opportunity to play a key role in the development and mentoring of staff whilst 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 special interest in Chemistry, Manufacturing, and Controls (CMC) development of small molecule pharmaceuticals of human medicinal products.
- 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).
- Extensive experience in CMC strategy and a minimum of ten years of experience in CMC development for small molecule NCE, with a strong background in pharmaceutical development, manufacturing, and regulatory compliance.
- Expertise in CMC-related regulatory requirements, including FDA, EMA, ICH guidelines, and GMP regulations for small molecules.
- Demonstrated experience with a broad spectrum of dosage forms for small molecule NCE and/or generic chemical entities.
- A minimum of ten years of regulatory experience, working with either FDA, and/or MHRA/EMA/TGA submissions, including meetings/negotiation.
- Regulatory experience may include time within a National Competent Authority.
- Experience with a broad range of products would be beneficial, 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, and live biotherapeutics.
- 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.
- Experience in consultancy and/or an outgoing personality that supports the ability to showcase their expertise and the business to new potential clients.
- 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.
Principal Regulatory Affairs Consultant (CMC Small Molecules) employer: Scendea
Scendea is an exceptional employer that fosters a collaborative and innovative work culture, providing employees with the opportunity to grow their careers in the dynamic field of regulatory consulting. Located in Bishop's Stortford, UK, our team enjoys a blend of in-office collaboration and remote flexibility, along with comprehensive training and mentorship programs that empower staff to excel in their roles. Join us to make a meaningful impact in clinical development while benefiting from a supportive environment that values professional growth and high-quality client service.
