Global Regulatory Affairs Specialist

JR Italy; Milano; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

Join a leading pharmaceutical company as a Global Regulatory Affairs Specialist in Milan. This role offers an exciting opportunity to leverage your regulatory expertise in a dynamic international environment. You will be responsible for leading regulatory submissions, developing engagement strategies with health authorities, and ensuring alignment with company objectives. With a focus on innovation and collaboration, this position allows you to contribute to the lifecycle management of groundbreaking products. If you're passionate about making a difference in the pharmaceutical industry, this is the perfect opportunity for you.

Servizi

Competitive salary package

Permanent contract

Chemical contract

Competenze

• 3+ years of experience in Regulatory Affairs.
• Strong understanding of drug and biologics development.

Mansioni

• Lead regulatory submissions and ensure compliance with health authorities.
• Develop engagement plans and strategies for regulatory interactions.

Conoscenze

Regulatory Affairs

Clinical Development

Lifecycle Management

Project Management

Multicultural Sensitivity

Strumenti

Veeva Vault

Descrizione del lavoro

Global Regulatory Affairs Specialist, Milano

Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with over 80 years of experience in the pharmaceutical and biotechnology industry – is expanding its team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment.

Purpose:

As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to contribute to the definition and execution of aligned EU, extra-EU, and/or global regulatory strategies. Work flexibly across regions to ensure business objectives are met. Support the development and execution of global regulatory strategies to support the TPP and ensure alignment of TPP with core product labelling for development and lifecycle management.

Main Responsibilities:

1. Serve as a regional/local regulatory lead and point of contact internally and with health authorities.
2. Contribute to the development of global health authority interaction strategies in collaboration with GRT.
3. Develop, independently or with guidance, health authority engagement and interaction plans for assigned products, including authoring and leading meetings.
4. Ensure accurate communication and tracking with relevant health authorities.
5. Lead regulatory sub-teams to ensure NDA/MAA/Extensions/Variations filings meet timelines and develop core global dossiers.
6. Align regulatory submission timelines with program and company objectives.
7. Contribute to content and review of regulated documents.
8. Support operational and compliance activities for deliverables and health authority contact reports.
9. Assist with GMP, GCP, and GPV inspections from health authorities.
10. Provide updates on project and submission statuses at GRT meetings.
11. Support updates to affiliates and interactions with IMDD and partners.

Experience Required:

Approximately 3 years of experience in Regulatory Affairs.

Skills and Qualifications:

• Understanding of clinical development of drugs and biologics.
• Knowledge of lifecycle management activities in EU and major extra-EU countries.
• Proficiency with electronic document management systems like Veeva Vault.
• Ability to handle multiple projects simultaneously.
• Sensitivity to multicultural and multinational environments.

Soft Skills:

• Stress management
• Time management
• Planning and organizational skills
• Strategic thinking

What We Offer:

• Competitive salary package
• Permanent contract
• Chemical contract

IQVIA reserves the right to evaluate candidates with relevant domicile, residence, work experience, or studies. Applications without the required qualifications will not be fully considered. Please provide authorization for personal data processing in accordance with GDPR (Regulation 679/16). This research is urgent and open to candidates of all genders (L.903/77).