Apply for Head of RA via BioTalent

Head of Regulatory Affairs f/m/d

Your Responsibilities

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.

Your Profile

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