Eu&Int Regulatory Affair Manager

Iqvia Italia; Trieste/Trst; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global pharmaceutical company is looking for a Regulatory Affairs Manager to develop strategies and manage regulatory submissions for Emerging Markets. The ideal candidate will have 3 to 5 years of experience in regulatory affairs, a Life Science degree, and strong communication skills. This role offers a challenging environment where you will work both independently and as part of a team.

Competenze

• 3 to 5 years of experience in corporate regulatory affairs roles.
• In-depth knowledge in drug development.
• Experience in leadership and coaching is a plus.

Mansioni

• Develop regulatory strategies for Emerging Markets.
• Manage regulatory submissions throughout product life cycles.
• Advise on regional regulatory requirements.

Conoscenze

Regulatory strategies development

Collaboration with consultants and partners

Regulatory requirements knowledge

Written and oral communication

Time management

Analytical skills

Formazione

Life Science Degrees

Descrizione del lavoro

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