Biologist - Regulatory Operations Maintenance Management (m/f/d)

Beschreibung

Almirall is an international pharmaceutical company headquartered in Barcelona, Spain. As a company committed to research, we put our strategic focus on dermatological health. Almirall sets high standards in the development and commercialization of innovative drugs - such as biologics - for the treatment of psoriasis and atopic dermatitis as well as other dermatological conditions like actinic keratosis, acne and nail diseases. Another focus is on the field of neurology. Our highly qualified and motivated employees support our success on a daily basis.

Come and join our team in Reinbek, Germany, as soon as possible, as

• Maintain marketing authorizations for Almirall products worldwide (variations, renewals etc.), define regulatory strategy/procedure and manage related internal and external resources, liaising with a variety of internal and external stakeholders (R&D departments, Project Management, Quality Assurance, health authorities, partners etc.)
• Manage regulatory matters concerning cosmetic products (preparation and update of the product information file, the safety assessment and CPNP notification activities) and food supplements
• Participate in clinical and non-clinical assessment of new external projects/products already marketed and in negotiating contracts with licensee companies
• Lead the preparation and maintenance of annual planning of all regulatory procedures to be performed and participate in drawing up and integrating the department budget
• Coordinate the compilation of documentations for maintenance of regulatory procedures, ensuring they are presented to partners, market companies and health authorities within established deadlines
• Ensure the development, implanting and maintenance of tools for document management, filing and flow in the department
• Request the implementation of regulatory changes that affect packaging materials, participating in the internal approval of materials loop
• Supervise and support team members, select consultants and service companies and coordinate and monitor their work
• Represent the company in regulatory matters in meetings held with other company departments, external companies or health authorities and keep abreast of international legislation/regulation in this field

• Degree in biology, pharmacy, medicine or chemistry
• Proven track record in a similar position in the pharma industry with experience in pharmaceutical legislation and international registration procedures
• Leadership skills
• Good communication skills in English in dealing with various stakeholders at the international level; other languages desirable

• 13 salaries per year and holiday allowance as an additional contribution
• Employer-funded supplementary health insurance
• 30 days of annual leave
• Attractive bonus system
• Company pension scheme, capital-forming payments