Senior Regulatory Affairs Specialist (m/w/d) CMC

Our client is an international company, that offers tailor-made support in the framework of all agenda concerning regulatory affairs.
For their team of highly skilled specialists in Vienna we are currently recruiting for this role: 

Senior Regulatory Affairs Specialist (m/w/d) CMC

What’s in it for you?  

• An attractive and complete salary package from € 60.000-75.000,-
• A good working atmosphere to thrive within the life sciences
• Possibility to grow: Sustainable careers and meaningful connections
• You’ll work for an international company, which aims to create a joyful community where you dare to be and can be yourself
• A good public transport accessibility (U6)

What can you expect?

• You deal with and respond to routine regulatory queries for information and documents in a timely, priority driven manner
• You prepare, compile, review and/or submit regulatory documentation to regulatory authorities and Notified Bodies 
• You write Module 3 documents – CMC
• You draft & review INDs/IMPDs for biopharmaceuticals
• You handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, National, Mutual Recognition and Centralized Applications, medical device CE marking and food supplement notifications
• You complete International product registrations and export certifications as requested by clients and international regulatory agencies in the EU and in third countries
• You perform dossier and development gap analysis (drugs, food supplements) and maintain current technical files and declarations of conformity in accordance with the Medical Device Directives 
• You respond to customer queries and questionnaires for regulatory information

 
Who are we looking for?

• You have a master’s degree (PhD preferred) in a relevant subject: biotechnology, chemistry, biology or a similar background
• You have 3-5 years of experience in a similar position.
• You have experience with writing module 3 documents, CMC and IMPDs.
• You are proficient in English and German. Other languages are a plus.
• You are computer proficient and can work with a variety of databases, word processing, spreadsheet, etc.
• You are able to create effective reports and analysis and you can communicate them in a timely and effective manner. 
• You are able to work in a team environment with shifting priorities and requirements. 
• You have excellent communications and organizational skills
• Willingness to Travel from time to time