To cover temporary leave employment from 04 March 2019 to 26 October 2019.
Duties and Responsibilities
Ensure support to the Regulatory Liaison team (EMEA and Global) for proactive interactions with other Incyte functions, contract research organizations, partner companies, and health authorities.
Ensure tracking of reporting obligations in the RIMS system and proactively inform the Regulatory Liaison team of upcoming submissions.
Plan and lead with Regulatory Liaison the preparation, review, and approval of compliant documents for regulatory submissions throughout the product lifecycle.
Manage (by European or Global Regulatory Operations) the electronic publishing of regulatory submission documents according to ICH, Competent Authority and company defined standards (CTA, MAA, eCTD, etc.) in compliance with technical validation requirements and in accordance with agreed timelines for regulatory submissions in the assigned regions.
Co-ordination of packaging and labelling activities between Regulatory Affairs, Regulatory Consultants and Supply Chain.
Artwork QC of packaging proofs/mock-ups vs. Product Information.
Contribute positively to a strong culture of business integrity and ethics.
Act within compliance and legal requirements as well as within company guidelines.
Requirements
Use of Microsoft Office and project management experience.
Minimum of 3 years pharmaceutical regulatory operations experience of pharmaceutical regulatory operations with use of eCTD software and Adobe Acrobat desktop publishing.
Experience with industry standard DMS.
Experience with publishing clinical trial applications and eCTD MAA lifecycle submissions.
