Diamond BioPharm Limited Job Specification CMC Consultant/Senior CMC Consultant Reports to: CMC Senior Manager/Director Based at: Harlow/Cambridge Job description: Diamond BioPharm Limited is a Regulatory consultancy company dedicated to providing high quality and competitively priced services to the biotech and pharmaceutical industries. This role is to carry out duties as assigned so as to maintain the projects in accordance with the business needs and to actively seek new business opportunities. General Responsibilities and duties of organisation:  To write or review all types of simple & complex variations  To write, review & submit clinical trial application forms (incl IMPD’s, IB’s)  Compile MAA – Modules 1‐5 (as applicable)  Write & Review SOP’s/Processes  Write/Review sections of dossiers for Centralised/Decentralised procedures (Focus on Module 3)  Project Management of all Regulatory requirements Key Responsibilities and duties of role:  Write/Review scientific sections of development plans, manufacturing & analytical development  Write/Review CMC aspects of Regulatory documents (incl Module 3, IMPD’s/IB’s)  Provide expert scientific and strategic advice  Scientific Advice Packages/Meetings with authorities  Project Management/lead responsibilities  Client Facing with strong communication skills, willing to travel Professional Experience Essentials:  2:1 (or above) Degree in Science discipline (Chemistry, Biotechnology, Biochemistry, microbiology)  PhD linked to Pharmaceutical industry (Preferred but not essential)  Strong understanding of the regulatory environment including guidelines  Experience with Biological products  ATMP experience (preferred)  Minimum of 5 year’s experience of product development including analytical, process & vector development  Ability to work under pressure and achieve timely submission and regulatory approvals  Good computer skills Personality attributes  Confident/Enthusiastic/Outgoing  Ability to work on their own or as part of a team  Self‐motivated with excellent communication skills  Well organized and good planning abilities  Good eye for detail  Multi‐tasking Page 1 of 1