Full-time - Hybrid Role - UK

IMC are currently supporting a UK head quartered client to hire a technical Clinical Development Senior Consultant, Supporting Global Pharma & Biotech clients with Product Development & Regulatory services. Their international team offers strategic and operational support in the fields of Non-Clinical/Toxicology, CMC, Clinical/Medical and Regulatory. Clients include early phase development through to clinical stage development up to and including MAA/NDA/BLA. The role offers a wide exposure to multiple Indications and types of products, including Small Molecules, ATMP's, Biologics and many more.

You will be joining a growing company with team members in the UK, US, Ireland, the Netherlands and Australia. The company is currently experiencing a significant period of growth, with ongoing plans to add service lines to facilitate the delivery of expert and strategic global regulatory consulting services to its global client base.

If you have 5-10 years Drug Development/Regulatory experience, this will offer a wonderful opportunity to continue your professional development.

The Role

You will be a technical Clinical Strategy expert joining the team on a full-time basis as a Senior Consultant (5-10 years exp). The position requires that you have established experience in working independently and leading technical discussions on a range of clinical development topics in compliance with current regulatory requirements. You will be competent in direct hands-on clinical writing and review of documents for regulatory submissions.

This is an excellent opportunity to progress your career at a growing global 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.

• Provide strategic, technical, and regulatory advice/services to clients in clinical development of human medicinal products, across a wide range of therapeutic indications & activities
• Provide innovative drug development plans, data gap analysis and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment
• Support company Business Development activities including:
o Sales/marketing introductions
o Preparation of project proposals & educational materials
o Review written estimates & quotations for accuracy
• Contribute to technical authorship and review of development regulatory documents, focusing on FDA, EMA & MHRA activities
• Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections
• Ensure delivery of project goals within agreed timelines and project budgets
• Identify and generate additional business opportunities from current Clients through exceeding expectations relating to the quality, delivery time and cost of services
• Educate clients on current regulatory trends and expectations
• Establish and maintain a high level of technical knowledge in product development and international regulatory affairs
• Challenge the regulatory boundaries from a technical and scientific standpoint
• Participate with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities

Location & Reporting Structure

• The role will be affiliated to their UK office
• The role will be flexible, working from home with a minimum of one office-based day per month
• The selected candidate will report directly to the Principal Consultant

Skills and Experience

• A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD)
• At least five years of drug development experience, with 3 years in biotechnology and regulatory affairs
• Clinical development experience across a range of therapeutic indications/disease areas
• Preference for candidates with significant experience in drug development covering Europe, UK, and the United States
• Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues
• Preference for candidates who have direct experience in providing strategic regulatory planning for the delivery of industry development goals, up to marketing authorisation
• Experience in negotiation with multinational regulatory authorities including, including, European, UK and US authorities.
• A professional manner and presentable appearance for meeting customers/clients
• Ability to work in a proactive and autonomous manner
• Ability to balance competing priorities and complete work within a set timeframe
• Exemplary organisational skills with a high level of attention to detail
• Exemplary verbal communication and presentation skills in English
• High level of computer literacy and competency in MS Office programs
• Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, Europe, UK or internationally.

Salary & Benefits Include

• A Competitive Salary
• Company Bonus Scheme
• 26 Days Holiday Plus additional days for Birthday & Work Anniversary & all public holidays
• 5% employer pension contribution
• Private Healthcare
• Employee Assistance Programme
• Employee Ownership Trust Scheme

To be considered for this role you must have unrestricted Right to Work in the United Kingdom