Regulatory Affairs Manager; Biosimilars (d/f/m)

at  Sandoz

ESSENTIAL REQUIREMENTS:

• University degree in a life science (e.g. pharmacy, chemistry, biology or similar) ideally PhD or comparable qualification
• Minimum 2 years work experience in the pharmaceutical or biotech regulatory affairs
• Self-organized, structured way of working, high quality awareness, proven team player
• Good communicator
• Ability to interpret scientific data and to construct persuasive regulatory documents
• Ability to work in an environment with changing priorities
• Proficiency in English (oral and written)
• Knowledge of Microsoft Office

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but are not limited to:

• Life Cycle Management of Biosimilar products registrations (new registrations, variations, PSURs and renewals) in EU, US, international region (80+ countries)
• Evaluate regulatory requirements and provide regulatory strategies when preparing or managing the timely delivery of high quality documentation required for initial marketing authorization applications and dossier updates worldwide
• Communication with Health Authorities (HAs), where applicable
• Develop and implement plans for timely response to HA requests and coordinate responses
• Drive coordination, planning, and submission of dossiers in assigned regions worldwide
• Review of global dossier summary documents
• Partner with regions to align on regulatory strategy in order to fulfil business objectives
• Act as representative of regulatory functions in cross-functional project teams and workstreams

IMAGINE WHAT YOU COULD DO HERE AT SANDOZ!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 64.023,54/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.