Sr. Director Head of Regulatory Affairs Germany(m/w/x)

Beschreibung

As the strategic lead for regulatory affairs in Germany, you will drive organizational vision and ensure compliance while mentoring a high-performing team to deliver life-changing innovations.

Anforderungen

• •Expert leadership and cross-functional influence skills
• •Excellent vision and direction setting
• •Senior-level experience with HA and Trade Association
• •Expertise in regulatory strategy and HA discussions
• •Leadership of complex cross-functional projects
• •Expert people management and development experience
• •Extensive internal and external cross-functional networks
• •Expert influencing, negotiation, and decision-making skills
• •Excellent decision-making and prioritization skills
• •Excellent verbal and written English skills
• •16+ years RA experience or 14+ with advanced degree
• •Expert knowledge of ICH and regulatory requirements
• •Expertise in complex regulatory strategy and negotiations
• •Excellent knowledge of QA and pharmacovigilance
• •Expertise in leading cross-functional project teams
• •Excellent people management experience
• •Expert knowledge of national and regional HAs

Aufgaben

• •Define vision and direction for the German regulatory organization
• •Provide strategic advice to the German leadership team
• •Ensure fulfillment of all marketing authorization requirements
• •Lead functional crisis management within the region
• •Manage German resource and budget planning
• •Communicate organizational changes to the regulatory team
• •Oversee professional development and succession planning
• •Direct all regulatory activities and deliverables in Germany
• •Advise on complex scientific and pre-submission meetings
• •Contribute to international and global regulatory strategies
• •Maintain compliance with local laws and global procedures
• •Participate in global improvement initiatives and taskforces
• •Advise promotional material review and quality assurance teams
• •Lead risk assessments and develop mitigation strategies
• •Monitor and prepare for changes in regulatory legislation
• •Mentor and coach regulatory and non-regulatory staff