Senior Manager Regulatory Affairs Strategy (m/f/x) | Munich area / hybrid

The increasing demand for specialized knowledge related to our European operations has necessitated the creation of a new position in one of our European offices, including Germany. This role, positioned at the Senior level, will be independent working and leadership in direct interactions with EU Regulatory and with business partners. The primary focus will be supporting development activities and managing teams.

What will your tasks as "Senior Manager Regulatory Affairs Strategy (m/f/x)" be?

• Develop regulatory strategy aligned with company goals
• Oversee design of clinical studies
• Coordinate preparation, submission, and tracking of study and regulatory applications in EU and USA
• Manage medical writing and ensure compliance with relevant laws and regulations
• Lead and develop Regulatory Affairs and Drug Development team
• Coordinate collaboration with external service providers involved in the study and the marketing authorization process, in particular CROs.
• Regularly present project progress and status to leadership team and executive management
• Responsible for developing the regulatory strategy to achieve our regulatory goals in line with the company's objectives.
• Work closely with other departments, such as Quality Assurance, to achieve regulatory objectives.

Your requirements as "Senior Manager Regulatory Affairs Strategy (m/f/x)"?

• Degree within a scientific field
• 5+ years' experience in regulatory affairs, with a primary focus on guiding products through the clinical development process.
• Experience in managing and developing staff members is desirable.
• Familiarity with interactions with the EU & FDA
• Preferred experience in shaping EU regulatory strategies
• Ability to negotiate and concisely express clear positions to stakeholders at all organizational levels.
• Direct experience in working with national regulatory agencies and leading face-to-face agency meetings.
• Business-fluent written and spoken in English and German

What does the role as "Senior Manager Regulatory Affairs Strategy (m/f/x)" offer to you?

• Depending on previous experience, there is a chance to specialize more towards the Development or Commercial site of the clients pipeline
• Hybrid working model with 40% homeoffice possible
• New position: New know-how and strong team players needed 😊
• 30 Days of holiday

Information about our client:
The company is an international healthcare incubator active in various areas such as intelligent bacteria, innovative pain therapies, chemical-free drugs, medical cannabis and rare diseases, works with over 20 companies and has more than 70 drug approvals.

Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!

My contact details:

• Email: s.revesz@sciproglobal.de
• Tel: 0049 (0) 89/ 26 200 311 (direct dial)

I look forward to your application!