Regulatory Affairs Management Director, Regulatory Science

**Position**: Regulatory Affairs Management Director (RAD), Regulatory Science & Execution,

Global Regulatory Affairs

**Location**: Paris - France (3 days working from the office and 2 days working from home)

**This is what you will do**:
The Regulatory Affairs Management Director (RAD), Regulatory Science & Execution will be **responsible for leading a team of regulatory affairs managers (RAMs) to develop and implement regulatory strategies for assigned products and regulatory jurisdictions**, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

This individual will, with a high sense of urgency, **lead a team of RAMs to provide operational and strategic regulatory input to cross-functional teams responsible for executing programs in relevant regulatory jurisdictions**. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

**You will be responsible for**:

- ** Leading a team of RAMs to develop and implement regulatory strategies for products and/or projects** in the relevant regulatory jurisdictions, as assigned, aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management.
- Providing advice and input to **internal Governance and advisory bodies** from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
- Actively collaborating with **Senior Management and Enterprise functions** (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise.
- Actively being up to date on **latest regulatory requirements and trends**.
- Serve as the **Subject Matter Expert (SME)** and provide guidance on major processes/platforms optimization where required.
- Work with **cross functional and other regulatory partners** to proactively identify areas of risk and improvement, as applicable.
- Drive **knowledge management** by sharing case studies/lessons learned from regulatory activities within the Regulatory Science & Execution.
- Ensuring **exemplary behavior, leadership, ethics and transparency** within the Enterprise, with Health Authorities and other external stakeholders.

**You will need to have**:
**Qualifications**
- 10+ years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies.
- Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment.
- Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
- Ability to build intra
- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
- Demonstrated ability to lead, mentor, and motivate team members to achieve organizational goals
- Strong interpersonal and written/verbal communication skills.
- Proven track record practicing sound judgment as it relates to risk assessment
- Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs in relevant areas and solid understanding of where to seek and how to interpret regulatory information.

**Education**
- Bachelor’s Degree, life science highly desirable
- Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
- Additional certification and/or training relevant to the role

**Competences**
- Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
- Proficient in English in the Corporate setting. Additional languages are a plus