Non Clinical Regulatory Director Home Based
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We are looking to identify a Senior Regulatory professional with an in depth understanding of the drug development process with particular focus on non-clinical development. You will provide expert non-clinical regulatory consultancy advice and services to internal and external clients, including regulatory strategy, preparation, review, submission and project management of regulatory applications as well as acting as the central point of contact for assigned key clients.
There is a negotiable salary available coupled with a large degree of flexibility regarding remote working.
- Providing expert regulatory consultancy advice and services to internal and external clients, including regulatory strategy, preparation, review, submission and project management of regulatory applications.
- Acting as the central point of contact for assigned key clients and to be a source of scientific expertise
- Contribute to providing strategy and vision for developing the group and working closely with sales and marketing to promote services offered by the group.
- Supporting a team of experts who are responsible for the delivery of Pharma Consulting services.
- Prepare, review, submit and project manage regulatory submissions in compliance with the applicable SOPs, regulatory guidelines and legislation.
- Attend client project meetings (face to face and via teleconference) as required.
- Provide input into monthly invoicing, and maintain financial control of assigned projects.
- Mentor other members of the organisation as required.
- Support day to day management of the group
- Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers
- PhD or BSc in Pharmaceutical Sciences or related relevant life sciences subject
- Extensive experience from working in a pharmaceutical/healthcare product development environment
- An in-depth knowledge and understanding of preclinical development is required
- An in depth understanding of the drug development process and the role of regulatory affairs within that process