||Regulatory Affairs Specialist
||Head of Regulatory Affairs
||Prague, Czech Republic
||Full Time Employment
This is a unique opportunity for an individual to work at a clinical-stage biopharmaceutical company where the global HQ is located in the Czech Republic. For the right individual, the experience that can be gained in this role can be an excellent next step for a successful career in the pharmaceutical industry.
Key Activities and Responsibilities
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 company’s 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.
Competences, Skills and Qualification
We are looking to hire an individual who is self-motivated, a quick learner, someone who is fully responsible for his/her own development, is solution oriented, has a can-do and proactive attitude and who is comfortable with ambiguity.
Pro-activeness and the ability to learn quickly on the job is essential to be successful in the role.
The ideal candidate would have the following academic and personal attributes:
- Education to at least Bachelor’s 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.
- Fluency in written and spoken English.
- Effective communication, organizational, administrative and planning skills.
- Analytical and problem-solving skills.
- Excellent attention to detail.
- Effective contributor within project teams.
- Ability to multi-task and prioritise as required.
- Ability to deliver individually and ensures the team delivers to agreed timelines.
- Excellent skills in spoken and written English and Czech
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