Senior Regulatory Affairs Manager Munich novel drugs

Our client is located in Munich and is developing novel drugs to treat major diseases. The company is currently looking for a new Senior Regulatory Affairs Manager.

This is an exciting opportunity for anyone who would like to participate in life-changing projects and enjoys the following duties and responsibilities:

Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. Contribute to the development and implementation of clinical, pre-clinical and CMC regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).

• Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
• Identify and assess regulatory risks for assigned projects or programs.
• Prepare and deliver effective presentations for external and internal audiences.
• Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
• Participate and contribute in Health Authority meetings.
• Represent regulatory on relevant project teams.
• Mentor other Regulatory staff members.

Qualifications:

• University degree required, Life/Health Sciences preferred.
• Minimum 6+ years pharmaceutical industry experience, 5 years regulatory experience.
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Demonstrate excellent communication skills.
• Ability to represent the department in project teams.
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
• Demonstrated effective cross-cultural awareness and capabilities.
• Experience in interfacing with relevant regulatory authorities.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
• Knowledge and understanding of applicable regulations.
• Experience in interpretation of regulations, guidelines, policy statements, etc.
• Computer literate.
• Sensitivity for a multicultural/multinational environment.

Key Contacts and Interactions:

• Interact with multiple departments at all levels.
• Interact with a wide variety of outside contacts, including contractors, corporate partners and regulatory agency personnel.

If you want to find out more and are interested in other Regulatory Affairs vacancies as well, please contact me, Vivien Kis, under v.kis@nonstop-recruitment.com or alternatively you can reach me under + 49 / 8921-093363 or + 41 / 43-508-0817.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.