Pharmaceutical Scientist - Team Lead Regulatory Submissions (m/f/d)

Beschreibung

At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

Our global headquarters, STADA Arzneimittel AG, is located in Bad Vilbel near Frankfurt am Main. For the Regulatory Affairs division we are looking for you as

• Functional lead of a small team of regulatory colleagues
• Functional resource planning and allocation of tasks
• Responsibility for projects on operational level, i.e. maintenance and life-cycle activities for medicinal products (variations, renewals, PSUR submissions)
• Escalation management
• Collaboration in interdisciplinary teams
• Monitoring of internal and external deadlines applicable for the team
• Reporting and preparation of decision papers
• Participation and provision of expertise in strategic discussions together with department head

• University degree with at least 2 years experience in Regulatory Affairs or alternatively professional education with a sound long-term RA experience
• At least 2 years experience in Regulatory Affairs, preferably in a position with life-cycle context
• Leadership qualities
• Very good communication and social skills
• Decision-making expertise
• Process-oriented mindset and problem-solving attitude
• Very good command of English, preferably also German
• Substantial knowledge of the legal framework for Regulatory Affairs for medicinal products in the EEA