Regulatory Affairs Director
Vor 5 Tagen
A modern manufacturer of pharmaceutical active substances and intermediates with a nearly 150-year-old tradition, serving generic and research-based pharmaceutical companies on five continents.
Job SummaryWe are seeking an experienced Head of Regulatory Affairs to lead our regulatory team and ensure compliance with applicable standards.
Key Responsibilities- Manage the Regulatory Affairs team, providing leadership and training to ensure alignment with regulatory standards and organizational objectives.
- Develop and implement regulatory strategies, setting clear timelines and priorities to meet regulatory deadlines effectively.
- Drive continuous improvement, optimization, and digitalization initiatives within the Regulatory Affairs department.
- Act as the main regulatory liaison for stakeholders to ensure alignment on strategic decisions and organizational objectives.
- Represent and advocate for the company's interests in dealings with regulatory bodies and key stakeholders.
- Independently manage regulatory projects, consolidating data from various departments to produce regulatory reports and dossier sections.
- Candidate must have a completed university degree (preferably as a pharmacist or chemist), ideally with a Ph.D. and a Masters in Drug Regulatory Affairs.
- Minimum of 5 years of experience in Drug Regulatory Affairs.
- Demonstrated experience in team and personnel management.
- Proficient in English and German (fluency required); additional languages such as French or Spanish are an advantage.
The estimated salary for this role is €80,000 - €120,000 per year, depending on qualifications and experience. Additional benefits include financial support, flexible working hours, comprehensive health insurance, retirement plan, professional development opportunities, and more.
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