Head of Regulatory Affairs, Europe
vor 2 Wochen
Our client is a dynamic and rapidly growing biotechnology company dedicated to developing innovative treatments for patients with serious medical conditions and life-limiting diseases. They are committed to transforming lives through groundbreaking therapies and are seeking a strategic yet hands-on leader to join their team.
Position Overview: They are looking for a highly experienced and motivated Head of Regulatory Affairs to shape and execute their regulatory strategy across Europe, with a focus on Eastern European countries. This role is pivotal in ensuring the successful launch and ongoing regulatory compliance of their cutting-edge treatments. The ideal candidate will have a proven track record in bringing innovative treatments to market and will thrive in a fast-paced environment.
Key Responsibilities:
- Strategic Vision and Execution: Develop and implement comprehensive regulatory strategies to support the approval and commercialization of their innovative therapies across Europe.
- Regulatory Submissions: Lead the preparation, submission, and management of regulatory applications, including Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), and other regulatory filings.
- Compliance and Oversight: Ensure ongoing compliance with all applicable regulatory requirements and guidelines. Monitor changes in the regulatory landscape and adapt strategies accordingly.
- Stakeholder Engagement: Serve as the primary point of contact with regulatory authorities, building and maintaining strong relationships to facilitate the approval process.
- Cross-Functional Collaboration: Work closely with internal teams, including clinical development, quality assurance, and commercial operations, to ensure alignment on regulatory strategies and objectives.
- Documentation and Reporting: Maintain meticulous records of regulatory activities and provide regular updates to senior management on regulatory progress and challenges.
Qualifications:
- Experience: Minimum of 10 years of experience in regulatory affairs within the biotechnology or pharmaceutical industry, with a focus on innovative treatments for serious medical conditions.
- Knowledge: In-depth understanding of European regulatory requirements, with specific experience in Eastern European markets being highly desirable.
- Education: Advanced degree in life sciences, pharmacy, or a related field.
- Skills: Strong strategic thinking and problem-solving abilities, coupled with a hands-on approach and attention to detail.
- Communication: Excellent verbal and written communication skills, with the ability to effectively interact with regulatory authorities and internal stakeholders.
- Self-Motivation: Ability to work independently in a remote setting, demonstrating initiative and a proactive approach to managing regulatory activities.
What They Offer:
- A unique opportunity to make a significant impact on the lives of patients with serious medical conditions.
- The chance to work with a passionate and dedicated team in a fast-growing biotech company.
- A flexible remote working environment with a competitive salary and benefits package.
- Continuous professional development and opportunities for career growth.
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