# Associate Director, Regulatory Affairs

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Bucuresti-Romania/Associate-Regulatory-Affairs-Director--Europe-SME_R1562523?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f2a48fea-be9

## Description

At IQVIA, our Global Regulatory Affairs team partners with pharmaceutical and biotechnology companies worldwide to navigate increasingly complex regulatory environments and accelerate patient access to innovative therapies.

We are seeking an experienced Associate Director, Regulatory Affairs to provide strategic leadership across European regulatory activities while leading and developing a team of regulatory professionals across the region.

**Responsibilities**

- Lead and oversee complex European regulatory activities across the product lifecycle, including market applications, lifecycle management and post-marketing submissions

- Provide strategic guidance on European regulatory procedures, including Centralised, Decentralised, Mutual Recognition and National procedures

- Partner with clients as a trusted regulatory advisor, supporting regulatory strategy, governance discussions and decision-making

- Contribute to proposal development, bid defense meetings and business growth initiatives

- Lead, coach and develop Regulatory Affairs professionals within a global matrix environment

- Support resource planning, forecasting and operational excellence initiatives

- Drive continuous improvement while ensuring high-quality regulatory delivery

**Requirements**

- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or a related discipline

- Extensive Regulatory Affairs experience with strong knowledge of European regulatory requirements and submission pathways

- Significant people management and leadership experience

- Experience supporting marketed products, post-marketing activities and lifecycle management

- Proven success managing complex regulatory programmes and stakeholder relationships

- Strong communication and presentation skills with the ability to influence internal and external stakeholders

- Commercial awareness and an interest in contributing to proposal development and business growth activities

**Additional advantages**

- Experience with biologics products

- CRO, consultancy or client-facing Regulatory Affairs experience

- Experience participating in proposal development or bid defense activities

**Why IQVIA?**

You'll join a global team of regulatory experts helping shape the future of healthcare while building and leading high-performing teams. This role offers broad exposure to regulatory strategy, commercial partnership and leadership opportunities, with potential progression into broader Global Regulatory Affairs leadership positions.

## Skills

### Required
- Life Sciences
- Pharmacy
- Biotechnology
- Chemistry
- Regulatory Affairs
- European regulatory requirements
- submission pathways
- people management
- leadership
- communication
- presentation

### Nice to have
- biologics products
- CRO
- consultancy
- client-facing Regulatory Affairs
- proposal development
- bid defense activities

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