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    Global Regulatory Submissions Lead

    Fortrea
    2+ years
    Not Disclosed
    Remote - Europe Remote, USA
    10 Oct. 22, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Posting: Global Regulatory Submissions Lead at Fortrea

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

    Position Overview: The Global Regulatory Submissions Lead (Manager, Regulatory Submissions) will collaborate with peers across the organization to achieve client-centric delivery in a matrix environment, particularly focusing on collaboration with all stakeholders within Site Readiness. Please note that this is not a people manager position, and relocation support or sponsorship will not be provided.

    Essential Job Duties:

    • Oversee and ensure accountability for RA/IRB/EC/Third Body submissions, including submission strategy, timeline planning, and tracking against projected milestones.
    • Provide consolidated country requirements and regular status updates to the project team and clients.
    • Ensure compliance of deliverables with applicable regulations and client requests by preparing, reviewing, and providing input on core study documents.
    • Offer high-quality regulatory advice to project teams and clients by staying informed about current regulatory legislation and guidance.
    • Provide guidance on the application of the EU CTR in CTIS, manage user access, and act as a backup during team absences.
    • Review and input into Start-Up project plans and monitor compliance regarding submissions.
    • Maintain awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones, escalating any risks to the Start-up Lead.
    • Engage in quality assurance and risk management activities to ensure project deliverables are met, and initiate improvements for efficiency and quality.
    • Support audits and inspections as needed and assist in resolving any findings.
    • Present at external and internal meetings, including core team and client meetings.
    • Contribute to the development of the group through participation in process improvement initiatives and SOP development.

    Requirements:

    • Minimum 5-7 years of experience in the pharmaceutical industry or drug development in regulatory affairs.
    • Excellent communication, organization, and planning skills with strong attention to detail.
    • Extensive experience in leading clinical trial applications at a regional/global level.
    • Direct project management skills with the ability to work independently.
    • Understanding of governmental regulatory processes and regulations related to investigational drugs.
    • Bachelor’s degree or higher.
    • Fluency in English.

    #LI-Remote #LI-AA3

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

    Equal Opportunity Employment: Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual, without discrimination based on race, religion, color, national origin, gender (including pregnancy or medical conditions), family status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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    Bucharest |

    Makkah :

    Khulais | Najran | Jeddah | King Abdullah Economic City | Riyadh | Rabigh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |