Lead, Global Regulatory Submissions
LabCorp
Prague 4 - Chodov, Czechia
před 6 dny

As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries.

Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services.

Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Role Details :

The "Lead, Global Regulatory Submissions" will be responsible for the timely preparation of submissions to Regulatory Authorities in support of investigational and marketed products.

In this role, you will interact with Regulatory Authorities and with clients to support regulatory activities. You will also interact with internal and external stakeholders to provide guidance regarding Regulatory Authority requirements and project timelines and needs.

Essential Job Duties :

  • Prepare study documentation such as the core EudraCT Form (Annex I, II & III) and cover letter
  • Prepare routine submissions filed to Regulatory Authorities ( INDs / CTAs and NDAs / MAAs / CTDs). Will take ownership for specific pieces of work and may be the Regulatory Submissions lead for projects
  • Review / summarize scientific / research documents in preparation for submission to Regulatory Authorities
  • Assist in the coordination, collection and organization of data and information required by Regulatory Authorities
  • Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions
  • Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to assigned product / project areas
  • Assure compliance with regulatory requirements in relation to assigned projects
  • Participate in project development and regulatory strategy planning sessions
  • Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues
  • Provide guidance and supervision to more junior colleagues (this is not a line management role)
  • Education, Skills and Other Requirements :

  • Minimum of 3-4 years of experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development
  • Extensive experience in Regulatory Submissions
  • Strong communication skills and motivation to support less experienced team-members
  • Ability to work in a global and multi-cultural team setting
  • Bachelor’s Degree in Life Sciences or equivalent
  • Fluency in English
  • Labcorp is proud to be an Equal Opportunity Employer :

    As an EOE / AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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

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