Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Strategic Regulatory Affairs Leader (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Rhineland-Palatinate
Branche: Forschung und Entwicklung im Bereich Biotechnologie
Ihre Aufgaben:
- Responsibility for developing and implementing global regulatory strategies to secure and maintain market access
- Managing compounds through all phases of development, post-approval and lifecycle of the product is a main task
- Ensuring the business needs for the assigned product(s) are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all global regulatory requirements
- Accountability for the overall regulatory deliverables and milestones including the global regulatory strategy
- Leading, coaching and mentoring a global regulatory product team
- Working with cross-functional counterparts to provide global regulatory direction and strategy including e.g. regulatory risk analysis and development of mitigation plans
- Responsibility for the content of the global dossier and the core product label
- Supporting consistency and compliance to regulations
Ihre Qualifikation
- Graduate in pharmacy, biology, chemistry, pharmacology or related life sciences is required. PhD would be a plus
- A strong clinical foundation is required
- Profound experience in pharmaceutical regulatory affairs is needed
- Preferred candidates would have experience working in Regulatory Affairs across two or more geographic areas (e.g. USA, EU, Asia)
- Extensive experience interfacing with government regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
- Experience working in a complex and matrixed environment is required
- Fluent in written and spoken English. Good command of spoken and written German
- Demonstrated success in negotiation skills, strategic thinking, strong verbal and written communication and leadership
Skills:
- Regulatory Affairs Manager