Senior Global Regulatory Lead

The GRL is accountable for

• Full oversight and understanding of the product and the company strategy around the program /project
• A sound global regulatory science strategy
• Well functioning Product Regulatory Teams
• Delivering regulatory milestones
• Submission content and quality
• Successful and timely approvals
• Cost-efficient and compliant regulatory life-cycle management
• Sharing product knowledge with all relevant stakeholders

Duties and Responsibilities

• Responsible for directing global regulatory strategies for assigned projects and programs supporting the Biotechnology Business Unit
• Direct global regulatory strategies
• Direct global life cycle management of products
• Support change management activities in the post-approval stage
• Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks
• Provide regulatory guidance to company personnel throughout the research and development process. Represent regulatory science in the core teams
• Set strategic direction and leads global regulatory submission process with the Product Regulatory Teams, including marketing applications and core briefing packages
• Direct the organization and preparation of clear and effective submissions
• Prepare and deliver effective presentations for external and internal audience
• Analyize regulatory agency activities in areas of interest to Gedeon Richter. Assess impact on programs
• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
• Provide leadership on project teams and subcommittees in all areas of regulatory science and product development
• Provide regulatory assessment during due diligence of potential in-license projects and support business development decisions
• Provide input to the Leadership Team
• Maintain a global view as part of the whole regulatory team

Qualifications

• Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD)
• Relevant experience in managing regulatory projects in Europe and US
• Strong working knowledged and experience relating to CMC. Pre-clinical and clinical regulatory experience is an advantage
• Expert knowledge with respect to the global regulatory landscapes
• Experience in interpretation of regulations, guidelines and policy statements
• Experience and knowledge in preparation of major regulatory submissions and supportive amendments or supplements
• Foster effective, positive interactions with regulatory agencies, and corporate partners
• Ability to lead and influence project teams, committees, etc. to attain group goals
• Demonstrate excellent leadership, project management and communication skills
• Demonstrate strong organizational skills, including the ability to prioritize personal workload
• Ethical, scientific and intellectual integrity
• Excellent verbal and written communication and presentation skills in English

We offer

• Great opportunity for professional development in an innovation driven department
• Great reputation at a well established pharmaceutical firm
• Stability and a trustworthy workplace
• Work in multidisciplinary teams
• Training and development opportunities
• Medical services and life insurance
• Various sport and health opportunities
• Excellent work life balance