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
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