EU&INT Regulatory Affair Manager

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

The research is urgent and is intended for candidates of both sexes (L.903 / 77).