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Archiviertes Projekt - Regulatory Affairs Manager

Firmenname für PREMIUM-Mitglieder sichtbar

April 2020

Juli 2020


auf Anfrage




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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