Head of Regulatory Excellence

**The Position**:
Are you a strategic thinker with a passion for excellence and innovation? Do you thrive in a dynamic, collaborative environment where your actions can make a significant impact? If so, we invite you to explore an exciting opportunity with us.

We are seeking a Head of Regulatory Affairs Excellence to lead our team into the future. This pivotal role is at the heart of our organization, driving the strategic integration of internal priorities and external regulatory trends. You will be instrumental in fostering a culture of excellence across all areas of our regulatory affairs department, translating complex analyses into tangible plans that enhance our capabilities.

As a continuous change agent within our organization, you will have the opportunity to drive innovation, foster collaboration, and implement best practices to achieve our regulatory objectives. Your leadership will directly influence the efficient translation of our strategies into competitive regulatory strategies, maintaining compliance with global regulatory requirements.

This position can be filled in Germany (Ingelheim or Biberach) or in the US (Ridgefield).

***Tasks & responsibilities**:

- As a visionary leader, you will convert insights from internal and external trends into practical plans that enhance our regulatory affairs capabilities. You will harmonize internal priorities and external regulatory trends, driving continuous improvement and competitive advantage.
- You will spearhead our Regulatory Excellence group, leading the Capability Leaders for Development, Market Authorization, and the GRA Compliance and vendor oversight groups. Your leadership will be instrumental in driving performance and innovation.
- Collaborate with the Regulatory Performance and Analytics lead to execute benchmarking exercises and KPIs. Your strategic insights will help us gauge our performance and innovation compared to competitors.
- Lead a team of Regulatory Project Managers to develop and implement regulatory strategies-based plans. You will ensure these plans align with our organizational objectives and comply with relevant regulations and guidelines.
- You will lead GRA transformation projects, designing and implementing effective change management strategies. Your efforts will facilitate the adoption of new processes, systems, and organizational structures with mínimal disruption to ongoing operations.
- As a key member of the GRA Leadership Team, you will mentor and guide talent within GRA. You will facilitate patient access to safe and effective pharmaceutical products worldwide, navigating complex regulatory landscapes, mitigating risks, and fostering a culture of regulatory excellence within the organization.

***Requirements**:

- Master's degree in Pharmacy, Life Sciences, or Chemistry, with preference for a Doctoral Degree. Additional certifications such as Specialised Pharmacist or Master of Drug Regulatory Affairs, RAC certification are highly desirable
- Broad and in-depth expertise in regulatory affairs, ideally at both local and global levels, with strategic and operational experiences. Mastery in regulatory science and global regulatory requirements, guidelines, developments, and standards
- Proven leadership experience in creating a vision and strategy that inspires team members. Strong networking ability with both internal and external stakeholders
- Strong analytical and data-driven mindset with the ability to translate regulatory guidances into strategic project proposals. Proficient in analyzing and interpreting complex data and regulatory guidelines.
- Superior commercial acumen, deeply understanding the business environment, needs, and priorities of the company. Functions with high autonomy and efficiency, requiring mínimal escalation, even in complex strategic situations
- Outstanding interpersonal and communication skills, with a knack for building relationships and managing conflicts effectively Fluency with necessary computer software and willingness to embrace further opportunities presented by emerging technological advances.

***Ready to contact us?**:
If you have any questions about the job posting or process - please contact our HR Direct Team,

Recruitment process:
Step 2: Virtual meeting/One-site interviews starting from mid of May