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    Diamond Pharma Services is always pleased to receive speculative applications from individuals regarding potential opportunities within our organisation even if a role is not directly advertised. Please send a copy of your CV with a covering note to: careers@diamondpharmaservices.com

    No recruitment agencies at this time, thank you.

    As part of a continued phase of expansion, Diamond BioPharm Ltd, Diamond Pharma Services, Inc and Diamond Compliance & Quality Ltd have a number of exciting career opportunities available and are currently seeking to employ the following:


    1. Regulatory Affairs Assistant

    Reports to: Regulatory Affairs Manager/Senior Manager

    Based at: No 4 East Wing, Gemini House, Flex Meadow, Harlow, Essex, CM19 5TJ, UK

    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 assist with Prescribing Information tasks
    • To write or review 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/National procedures
    • Project Management of all Regulatory requirements

    Key Responsibilities and duties of role:

    • Draft, compile & submit variety of Regulatory documents
    • Assist with submissions
    • Learn/Understand legislation associated with Regulatory requirements
    • Client Co-ordination
    • Willingness to keep updated with Regulatory knowledge

    Professional Experience

    Essentials:

    • 2:1 (or above) graduate in relevant scientific discipline
    • Base level understanding of the regulatory environment
    • Ability to work under pressure and achieve timely submission and regulatory approvals
    • Good computer skills

    Personality attributes - Regulatory Affairs

    • 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

    Please apply by sending your CV and covering letter to careers@diamondpharmaservices.com

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    2. Senior Biologics or ATMP Regulatory Professional, Diamond BioPharm Ltd

    As part of our continuing growth we have a vacancy available for a senior regulatory professional with 5+ years biologics experience.

    Key Responsibilities and duties of the role:

    • A lead client facing consultant
    • Leads regulatory projects for clients with clinical stage biologics programmes
    • Expert regulatory documentation author with CMC experience preferred
    • Experience in IMPD or IND writing
    • Experience in MAA/BLA desirable
    • Experience preparing PIPs, Orphan Applications and Scientific Advice Meetings
    • Point of contact with regulatory authorities on behalf of clients

    Professional Experience

    Essentials:

    • Minimum of 5+ years biologics experience in a regulatory capacity
    • Biologics regulatory expert with demonstrable experience in liaising and negotiating with regulatory authorities
    • Experience in regulatory activities for biologics including monoclonal antibodies
    • 2:1 (or above) Degree in Scientific discipline
    • Strong understanding of the regulatory environment including guidelines
    • Proven ability to engage with potential clients across a range of cultures, backgrounds and disciplines
    • Excellent computer skills

    Personality attributes

    • Ability to work on their own and to be an influential leader of a team
    • Self-motivated and pro-active with excellent communication skills
    • Well organised and good planning abilities
    • Good eye for detail
    • Multi-tasking

    Please apply by sending your CV and covering letter to careers@diamondpharmaservices.com

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    3. Regulatory Affairs Manager, Diamond BioPharm Ltd

    Join us to work on a range of regulatory affairs projects across both pre- and post-authorisation.

    Expect to be involved in marketing authorisation applications, developing regulatory strategies and coordinating post-authorisation activities etc.

    Work in project teams with technical experts and fascinating clients.

    A regulatory affairs professional is sought on a permanent basis to provide regulatory affairs consulting services for small molecule and generic products. Experience in European regulatory affairs is required with experience in marketing authorisation application stage projects preferred. The position can be based from any our UK offices (Harlow, Stratford or Cambridge).

    The ideal candidate would be expected to have experience in any of the following:

    • Writing/Reviewing sections of dossiers for Centralised, Decentralised, national procedures
    • Co-ordinating licensing and post licensing procedures on behalf of clients i.e. Clinical Trial Applications, National, Mutual Recognition and Centralised Applications
    • Project Management/lead responsibilities
    • Writing/Reviewing all types of variations including submission
    • Updating/Reviewing SmPC & PIL (Co-ordinate Linguistic review process)

    Professional Experience

    • 2:1 (or above) graduate in relevant scientific discipline
    • 6+ years broad & deep regulatory affairs experience
    • Strong understanding of the regulatory environment including guidelines
    • In depth knowledge of all application types
    • Understanding of Mutual Recognition, Decentralised and Centralised procedures
    • Ability to work under pressure and achieve timely submission and regulatory approvals

    Please apply by sending your CV and covering letter to careers@diamondpharmaservices.com

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