European Head of Regulatory Affairs

vor 6 Monaten

Duesseldorf, Deutschland ARCHIMED Vollzeit

**About the company**

CRO is a leading Clinical Research Organization dedicated to advancing healthcare through innovative research solutions. With a focus on delivering high-quality clinical trials and comprehensive services, we strive to make a meaningful impact on patient care worldwide.

**Requirements**:
As the European Head of Regulatory Affairs, you will play a pivotal role in ensuring regulatory compliance and strategic oversight across our clinical research operations in Europe. Reporting directly to the US based Chief Operating Officer, you will lead a team of regulatory professionals and interface with regulatory agencies, sponsors, and internal stakeholders to navigate the complex regulatory landscape and drive successful clinical trial outcomes.

**Key Responsibilities**:
**1. Strategic Regulatory Leadership**:

- Develop and execute regulatory strategies aligned with business objectives and regional regulations.
- Provide guidance on regulatory requirements and implications throughout the product development lifecycle.
- Anticipate regulatory challenges and proactively identify solutions to ensure timely approvals.

**2. Team Management and Development**:

- Lead and mentor a team of regulatory affairs professionals, fostering a culture of excellence, collaboration, and continuous learning.
- Provide coaching and professional development opportunities to enhance team capabilities and expertise.
- Ensure resource allocation and workload management to optimize team performance and productivity.
- Participate in bid defense meetings and support proposal development

**3. Regulatory Compliance and Oversight**:

- Monitor regulatory changes and assess their impact on ongoing and planned clinical trials, providing strategic guidance to mitigate risks.
- Collaborate with cross-functional teams to address regulatory issues and deviations, implementing corrective and preventive actions as needed.

**4. External Stakeholder Engagement**:

- Serve as the primary point of contact for regulatory agencies, representing the company's interests and fostering positive relationships.
- Engage with sponsors, investigators, and external partners to address regulatory inquiries and facilitate regulatory interactions.
- Participate in industry forums, conferences, and working groups to stay abreast of regulatory trends and best practices.

**5. Quality Assurance and Compliance**:

- Ensure adherence to regulatory standards, guidelines, and SOPs, driving a culture of compliance and quality excellence.
- Conduct regulatory audits and inspections, collaborating with internal audit teams to address findings and implement corrective actions.
- Champion a proactive approach to risk management, identifying and mitigating potential compliance issues before they escalate.

**Qualifications**:

- Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (e.g., MSc, PhD, JD) preferred.
- Extensive experience (minimum 8-10 years) in regulatory affairs within the pharmaceutical, biotechnology, or CRO industry, with a focus on clinical development. CRO experience is essential.
- In-depth knowledge of European regulatory requirements and guidelines governing clinical trials and drug development (e.g., EU Clinical Trial Regulation, ICH guidelines).
- Proven track record of successful regulatory submissions and approvals across multiple therapeutic areas and phases of clinical development.
- Strong leadership and managerial skills, with experience leading and developing high-performing teams.
- Excellent communication, negotiation, and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
- Strategic mindset with the ability to anticipate regulatory trends and navigate complex regulatory challenges.
- Demonstrated ability to work in a fast-paced, dynamic environment, managing multiple priorities and driving results under tight timelines.

**Benefits**

CRO is an equal opportunity employer committed to diversity and inclusion. We offer a competitive salary and benefits package, along with opportunities for professional growth and development in a collaborative and supportive environment.

If you're passionate about regulatory affairs and driven to make a difference in advancing clinical research, we invite you to join our team and contribute to our mission of improving patient lives through innovation and excellence.

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