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Regulatory Affairs Associate

2 months ago

New York, United States South Bohemian Agency for Support to Innovative Enterprising (JAIP) Full time

For my client, prestigious biotechnological company I am looking for Regulatory Affairs Associate.
Job Requirement & Education:
The ideal candidate would have the following academic and personal attributes:
Education to at least Bachelors level in a scientific discipline
Prior experience in a GXP regulated environment
Good knowledge of the Common Technical Document (CTD) format
Good project management skills with the ability to manage several projects and competing priorities
Excellent

grammatical, editorial and proofreading skills
Very good English
In this role, you will provide regulatory support for product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting project teams. More specifically, you will:
Define content of regulatory submission dossiers and initiate review and approval of change control as required. Develop and Agree regulatory deliverables and conduct project delivery activities both with internal and external stakeholders to ensure all timelines are met.
Ensure quality authoring of core-administrative parts of submissions.
Contribute to or prepare administrative and technical components of regulatory agency submissions primarily for the global conduct of clinical trials (EU, US, China and other regions as required) and if applicable in the future for product registration, for post-approval maintenance, in common technical document (CTD) format. Contribute to the preparation of regulatory agency meetings and provide all administrative support for these agency interactions.
Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines and strategies.
Participate as regulatory support on multidisciplinary project teams, which may include nonclinical, clinical science, clinical operations, CMC and other technical subject matter experts, to develop products throughout their life cycle.
Ensure compliance with ICH/regional/country-specific regulatory requirement and the companys policies and processes.
Prepare

training materials for internal stakeholders and share best practices in the regulatory area.
Participate as regulatory support in internal or external project audits and on internal cross-functional initiatives.
Conduct as required research of existing product data and published literature relative to global or regional regulatory requirements for the preparation of gap analyses or product development plans.
Offer:
Very good salary
Professional growth, good team
Start date is upon agreement.
In sending your CV you give your consent to processing and holding of your personal data in accordance to Act. No. 101/2000 Coll. regarding personal data protection by LD Human Resources s.r.o., ID: 24275336 until a written form revocation. Your personal data can be provided to third persons in order to obtain employment, namely after prior approval.

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