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Archiviertes Projekt - Regulatory Affairs Manager

Firmenname für PREMIUM-Mitglieder sichtbar

April 2020

Juli 2020

CH-Switzerland

auf Anfrage

24.03.2020

CR/103056_1584974796

Projektbeschreibung

Our client is looking for an experience consultant who could support already existing applications and project mainly in post marketing stage.

Tasks required:

* Advise the Project /or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
* Drive understanding of central and national regulatory requirements
* Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
* Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
* Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling
* Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan
* Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
* Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate

* Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
* Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate
* Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions
* Ensure necessary regulatory activities are planned and adequately tracked in company systems
* Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
* Advise team on required documents and submission strategies in preparation of CTA
* Provide regulatory support throughout registration process
* Provide regulatory support throughout life-cycle management
* Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)

This is initial 4 months project and could be extended.

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