- Experience in preparation and management of regulatory documentation,normally a full international submission (current product application) or large variations
- Minimum 1 year of Regulatory affairs experience
"Your Role. The Specialist Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authoritiesrequirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach. Will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. You will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel.
Who You
Are. Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D; experience related to the role. Minimum 1 year of Regulatory affairs experience. Degree in a Life Science or a related discipline, preferably MSc.
Experience in preparation and management of regulatory documentation,
normally a full international submission (new product application) or large variations.
Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset).
Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally. Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtOs, AFs, CLs, PoAs etc.) as well as legalization framework. Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request.
Adherence to agreed timelines and proactive communication of any potential risk to the same. Project management and documentation skills, proactive communication approach. Contributor level of experience with RIM and EDMS RA applications.
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