We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Stellenbezeichnung: Head of Regulatory Affairs Germany (m/w/d)
Standort: Düsseldorf (Hybrid)
Stellenbeschreibung
Die Position des Head of Regulatory Affairs Germany in unserem Standort in Düsseldorf, Deutschland, berichtet direkt an den Head of Regulatory Affairs der EMEAC-Region mit Sitz in Zug, Schweiz. In dieser wichtigen Funktion übernehmen Sie die Verantwortung für strategische Aufgaben im Zusammenhang mit neuen und bestehenden Produkten in Deutschland. Ihre Aufgaben reichen von der Leitung des Regulatory Affairs-Teams und dem Aufbau funktionaler Kompetenzen bis hin zu Verhandlungen und Interaktionen mit Gesundheitsbehörden für Arzneimittel, Medizinprodukte und Kosmetika.
Hauptverantwortlichkeiten
- Development and implementation of the regulatory affairs strategy for new and existing products in Germany
- Leading the Regulatory Affairs team and building functional competencies
- Negotiations and interactions with health authorities for pharmaceuticals, medical devices and cosmetics
- Responsibility as Regulatory Information Officer according to § 74a, §8 AMG
- Management of regulatory activities for the entire product portfolio in different categories
- Ensuring compliance with product licenses and their timely updating
- Establish and maintain effective relationships with health authorities and standardization bodies
- Continuous adaptation to relevant regulatory developments and definition of strategies accordingly
Requirements
- Completed pharmacy studies or bachelor's degree in pharmaceutical sciences.
- Several years of experience in regulatory affairs for pharmaceuticals, medical devices and/or cosmetics.
- In-depth understanding of the pharmaceutical industry in Germany.
- Experience as Regulatory Information Officer according to §74a, §8 AMG.
- Excellent knowledge of German pharmaceutical legislation and regulation.
- Strong leadership skills and experience in leading teams.
- Negotiation skills and interaction with high-level stakeholders.
- Comprehensive knowledge of GxP regulations and SOPs.
What we offer
You will work for a company that is committed to diversity and inclusion and believes that we achieve better results when we reflect the perspectives of our diverse customer base.
Galderma Laboratories GmbH offers an open culture of mutual respect. Our new employees can look forward to, among other things:
- Market-based remuneration including an attractive bonus model
- Flexible working models with generous home office arrangements
- 30 days fixed annual leave and, depending on the time model and applicable company agreement, additional days off without counting towards annual leave!
- Employer-funded company pension scheme
- Weekly fresh fruit, water, tea and coffee available free of charge in the office
- Lunch vouchers for office staff, usable in many local shops
- Opportunity to participate in international projects
- Employee Recognition Program
Our people make the difference
At Galderma, you work with people like you. And people who are different. We value what each member of our team brings to the table. Professionalism, collaboration and a friendly, supportive ethos are the perfect environment for people who want to thrive and excel in their work.
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