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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 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. Biologics Regulatory Professional, Diamond BioPharm Ltd

    As part of our continuing growth we have a vacancy available for regulatory professionals with 2 to 4 years biologics experience.  

    Key Responsibilities and duties of the role:

    • 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 is desirable

    Professional Experience

    Essentials:

    • Minimum of 3+ years biologics experience in a regulatory capacity
    • 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 as part 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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    4. Clinical Trials Application Senior Associate/Manager, Diamond BioPharm

    Reports to: Regulatory Affairs Senior Manager

    Based at: No No 4 East Wing, Gemini House, Flex Meadow, Harlow, Essex, CM19 5TJ, UK or Cambridge Science Park, Milton Road, Cambridge, CB4 0FN or London Stratford, E15 2ST

    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. The Clinical Trials Application Senior Associate/Manager will take the initiative with the organisations Clinical Trial Activities.

    Key Responsibilities and duties of the role

    • Prepare and submit clinical trial applications and substantial amendments to competent authorities and ethics committees throughout Europe, with an emphasis on UK & IE submissions.
    • Preparation of submissions using IRAS and EudraCT systems
    • Review and extract information from clinical trial associated documentation (incl. IMPD’s, IB’s, EudraCT, Protocols & labelling)
    • Quality Control check junior member of staff work, correct where necessary & provide feedback.
    • Write, review and implement SOPs/processes
    • Be responsible for Clinical Trial Management Plans & interaction with clients for CTA related activities.
    • Client Facing with strong communication skills, willing to travel if required

    Professional Experience

    Essentials:

    • 2:1 (or above) graduate in relevant scientific discipline
    • 4+ years broad Clinical Trials Experience, covering competent authority and ethics submissions
    • Experience with IRAS system and HRA process for UK submissions
    • Strong understanding of the regulatory environment for Clinical Trial Applications
    • Ability to work under pressure and achieve timely submission and regulatory approvals
    • Good computer skills

    Preferable:

    • Previous experience within a CRO environment

    Personality attributes

    • Confident/Enthusiastic/Outgoing
    • Ability to lead a team
    • Self-motivated with excellent communication skills
    • Well organized and good planning abilities
    • Strong attention to detail
    • Multi-taskingPlease apply by sending your CV and covering letter to careers@diamondpharmaservices.com & click here to view the full job specification.

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    5. Regulatory Consultant, Biologics & Advanced Therapies

    Join us to work on exciting development stage ATMP and Biologics projects. This is an opportunity to push your career forward and gain experience that is hard to get working for the big biopharmaceutical companies.

    Expect to be involved in IMPD writing, orphan designation applications, paediatric investigation plans, scientific advice preparation etc.

    Work in project teams with technical experts and fascinating clients.

    A regulatory affairs professional is sought on a permanent basis to provide regulatory and product development consulting services for biologics and advanced therapies projects. Experience in European regulatory affairs is required with experience in development stage projects preferred. The position can be based from our UK offices (Cambridge or Harlow).

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

    • Adapting IMPDs/INDs preferably with CMC experience
    • Procedural experience
    • Regulatory project management

    Professional experience required:

    • A minimum of 5 years of European regulatory affairs experience with biologic products
    • 2:1 (or above) Degree in a scientific discipline (e.g. Chemistry, Biochemistry, Biotechnology etc.)
    • Strong understanding of the regulatory environment including guidelines
    • Outstanding organisation and communication skills

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

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    6. Senior Manager Compliance

    This exciting role will be to run the day-to-day activities associated with all GxP consulting tasks required by pharmaceutical clients and to ensure Diamond Compliance & Quality has the necessary quality systems and processes in place in order to meet all Quality and Regulatory GMP standards.

    The ideal candidate would be expected to have experience in:

    • Experience of working in the pharmaceutical industry or regulatory authority inspections division
    • Past experience in auditing manufacturing sites
    • Ability to work across a range of dosage forms (oral, topical, inhaled, injectable) and biological experience would be an advantage

    Professional experience required:

    • Degree, or above, in a scientific discipline (e.g. Chemistry, Biochemistry, Biotechnology etc.)
    • Strong understanding of the quality and regulatory environment including guidelines
    • Around 5-10 years' experience
    • Outstanding organisation and communication skills

    Please apply by sending your CV and covering letter to careers@diamondpharmaservices.com & click here to view the full job specification.

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    7. 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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    8. Regulatory Affairs Manager, Diamond Pharma Services, Inc.

    An exciting opportunity has arisen within our fast-paced and growing US subsidiary to support the Regulatory Affairs Director on a number of cell and gene therapy programs amongst other regulatory activities. 

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

    • Preparing FDA documentation (drafting/reviewing)
    • Experience coordinating and managing submissions to FDA
    • Regulatory project management

    Professional experience required:

    • A minimum of 4 years of US regulatory affairs experience with biologic products
    • 2:1 (or above) Degree in a scientific discipline (e.g. Chemistry, Biochemistry, Biotechnology etc.)
    • Strong understanding of the regulatory environment including guidelines
    • Outstanding organisation and communication skills

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

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