EU&INT 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&INT 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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