Auftragsdetails

In the role as Consultant Regulatory CMC you will be working on projects from a variety of Pharmaceutical and Biotechnology companies. On the projects you will be dealing with challenging and varied tasks that requires you to be result and client orientated and to display excellent interpersonal skills. At the same time you will have the opportunity to actively participate in the company’s continued development. You will provide services to our clients spanning all aspects of drug development field including regulatory strategy.

The location for this position is either the Netherlands, Sweden or UK.

These services include but are not limited to:

• Providing strategic advice related to Regulatory CMC.
• Writing and reviewing CMC documents.
• Defining CMC strategy for drug development projects.
• Participating as regulatory CMC expert in product development teams.
• Preparing and participating at national and EMA scientific advice.
• Preparing CMC sections for clinical trial applications, and marketing authorisation applications.

• Academic degree in a life science field.
• Minimum 5 years of experience in a CMC position within the pharmaceutical industry or health agency. Additional knowledge about biologics is a plus.
• Comprehensive understanding of CMC guidelines and requirements, drug development activities as well as product life cycle management from a regulatory affairs perspective.
• Excellent project management skills.
• Excellent communication skills (oral and written) in English and Swedish.
• Excellent in writing scientific and technical texts.
• Ability to execute multiple tasks or projects, being able to prioritise and meet project deadlines.
• Having an open eye for the needs of your customers and the ability to adjust to these needs.
• Willingness to dig into the details yet keeping an eye on the overall goal of the project

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***