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- Posted 04 January 2023
- Job type Permanent
- Contact NameDavid Skinner
Head of Regulatory Affairs f/m/d
- Develop regulatory strategies for Marketing Authorization Applications and subsequent maintenance activities of development products in EU and US, including the development of pediatric development plans.
- Be an expert in international regulatory aspects to effectively support all other units of the company.
- Represent the Regulatory Affairs Department during Agency inspections and meetings with external partners or scientific key opinion leaders.
- Provide regulatory input to strategic development plans and clinical investigation plans.
- Monitor changes in regulatory laws and regulations and evaluate the impact on the pharmaceutical industry in general and on the business in particular.
- Develop active networks for the Regulatory Affairs Department with internal and external stakeholders.
- Manage and ensure contractual agreements with external providers for regulatory services.
- Act as a contact and escalation point for regulatory matters, identify internal needs for training and new/changed procedures, as well as develop solutions to address knowledge gaps within the organization.
- Plan and control the financial budget for the regulatory affairs activities
- Ensure relevant regulatory SOP’s are developed and implemented to effectively support the needs of the business.
- Master´s Degree or PHD advanced degree in appropriate scientific discipline
- Minimum 5+ years of global regulatory experience in drug development and life-cycle management
- Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval
- Demonstrated leadership capabilities and ability to think strategically
- Demonstrated ability to integrate regulatory science with scientific/clinical knowledge
- Demonstrated track record of working in a multifunctional matrix biotech environment
- Experience in managing multiple projects and proactively plan
- Experience of all phases of the drug development process in Regulatory Affairs would be a plus
- Experience in working with strategic partners/cross company collaborations
- Experience in partnering with business development in due diligence efforts
- Excellent communication skills in English and German
- High level of commitment, flexibility & perseverance