Archiviertes Projekt - Regulatory Affairs Strategist (m-w-d)

Aktuell suche ich für ein pharmazeutisches Unternehmen in Berlin einen Regulatory Affairs Strategist (m-w-d):

Tasks:



Contributes to the development of local regulatory project goals from
development through life cycle.

* Participates in the preparations for meetings and teleconferences with local HA officials.
* Works with Lead GRS and supervisor to compile and submit IND and clinical trial applications to enable timely start of the clinical trials for the assigned development products.
* Works with Lead GRS and supervisor to develop submission materials for local HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission.
* Collects, reviews and analyzes competitor information, local Agency guidelines and precedence
* Keeps abreast of changes in the local regulatory environment for the project.
* Contributes to the development of the Briefing document for the local authority meeting for assigned projects. Responsible for entering submission material and other documents and relevant data into appropriate RA databases.
* Where applicable, reviews external and internal communications on local level for regulatory accuracy and local HA compliance.
* May act as the primary interface between the company and the local Health Authority (HA).
* May be involved in decision making on key development questions.
* May participate in ad hoc Global Project Team subteams or working groups as invited by the Global Project Team.
* May participate in a global regulatory team (GRT) and provided local regulatory input into the global development plan for assigned projects.

Qualification:

* Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life sciences with 2 years direct experience in biomedical research activities.; or MS with 4years of experience in biomedical activities; or BS with 6 years of experience in biomedical activities.
* Basic knowledge of local Health Authority (HA) regulations (FDA or EMA) t support filings
* Basic understanding of drug development (PK, PD, statistical concepts, data collection, endpoints, etc.)
* A thorough knowledge of company policies and procedures in drug development and product maintenance requirements



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