EU∫ Regulatory Affair Manager On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a
EU∫ Regulatory Affair Manager
who can join an exciting working environment in a dynamic atmosphere.
RESPONSIBILITIES
Develop regulatory strategies for the Emerging Markets countries to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives, with regional Head limited supervision
In collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD products
In full alignment with the regional Head, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products.
Contribute to the preparation and/or review of submissions to relevant markets to ensure the high quality of the documentation
In agreement with the regional Head, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissions
Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission.
Contributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory Affairs
In full alignment with the regional Head, provide regulatory guidance to colleagues from other functional areas
Provide regulatory expertise in support of due diligence assessments
Represent the Regulatory Department at the Core Team as a global RA member, where needed
Support the Regional GRD Regulatory Affairs Head in the preparation of the needed documents for the meetings and interactions with regional regulatory authorities
REQUIREMENTS AND SKILLS
Experience required : 3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in the drug development
Education : Life Science Degrees
Technical Skills
: good level
Soft Skills
:
flexible, collaborative, open minded
Well-developed written and oral communication and listening skills
Well-developed time management skills and demonstrated ability to manage complex assignments.
Experience in leadership and coaching is an asset.
Well-developed analytical and problem-solving skills.
Ability to work independently and as part of a team.
TYPE OF CONTRACT Chemical Contract
IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).
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