Eu&Int Regulatory Affair Manager

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 atmospherep>

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 considered.