Regulatory Affairs consultant with CMC competence

Technogarden is experiencing an increasing demand of skilled and experienced Regulatory Affairs specialist, preferably with CMC experience. Our clients are mainly clients are mainly consisting of pharma- and biotech companies so that former experience from these lines of businesses is an advantage.

Your range of experience within the field contains:

• Carrying out maintenance activities for registered products.
• Provide regulatory expertise in project teams throughout organisations and preferably also internationally.
• Maintain activities for registered products and regulatory impact assessment of CMC changes.
• Lead, manage and implement CMC submission activities for registered products including life-cycle management plans.
• Develop and improve processes and ways of working.
• Respond to CMC - and on occasion - other CMC questions from Health Authorities.

What we expect from you:

As a consultant at Technogarden you will represent both us and our customers by performing by example. You are both professional and representative and used to working independently at the same time as you blend in perfectly to a new team. You are structured and organized and deliver your work in a detailed and timely manner. Preferably you have minimum 3 years of experience from Regulatory Affairs and knowledge within relevant regulatory- related regulations and guidelines. You have a good understanding of drug development processes and knowledge within the CMC regulatory area.

We believe you have a Bachelor or Master of Science within Analytical Chemistry, Biochemistry or similar discipline. Further you have excellent communication and documentation skills in English. 

What you can expect from Technogarden

As a consultant with us you will be part of a growing, competent and happy team with different profiles - all busy within the Life Science industry in Southern and Western part of Sweden. We offer attractive conditions and an active group of professionals that also spend time together building strong bonds within our area of Business by means of socializing and exchanging knowledge and competence. Are you are next colleague? Give us a call and get to know more!