Senior Expert Regulatory Affairs - CMC Biosimilars (m/w/d)

Are you an expert in your field and ready to apply your expertise to exciting projects?

As part of the Hamburg-based TECCON Group with over 450 employees in IT, engineering, and business, we develop innovative solutions for renowned clients. Our goal is to recognize and nurture potential in people by creating tailored connections between companies and talents. Bring your expertise to our projects and help shape the future with us.

Deine Aufgaben

• Regulatory Affairs: Develop and implement a strategy for Regulatory Affairs that aligns with the business needs for biosimilars and ensures regulatory compliance.
• Submissions: Plan, prepare, and coordinate CMC-related submissions with the CMC and regulatory teams.
• Regulatory Input: Track approvals and collaborate with Quality, Supply, and CMC teams to implement changes.
• Cross-functional Collaboration: Work closely with other teams to represent the regulatory team in meetings and projects.
• Stakeholder Engagement: Present and defend the companys strategy in front of health authorities.
• Externalization: Manage external RA-CMC activities when needed.

Dein Profil

• Education: Masters degree in life sciences or a related field.
• Experience: 5-8 years of experience in Regulatory Affairs CMC, preferably in biotech.
• Product Knowledge: Experience with biological products, especially monoclonal antibodies (mAb).
• Regulatory Knowledge: Familiar with managing international regulatory submissions (BLA/MAA) and changes.
• Agency Interaction: Experience working with regulatory authorities.
• Language Skills: Excellent English, both spoken and written. Knowledge of another language is a plus.
• Communication Skills: Strong communication skills, both written and verbal.

Deine Benefits

• Exciting challenges and responsibilities with room for autonomy.
• Flexible working hours and remote options to balance professional and personal commitments.
• Long-term prospects in a dynamic and dedicated team.
• Diverse opportunities for development and further training.
• Engaging team events that strengthen team spirit and add variety.

Your starting salary will be at least EUR 75,000 gross per year, with the potential for market-competitive overpayment depending on your qualifications and experience.

TECCON Austria GmbH Concept Straße 1 8101 Gratkorn