CMC Regulatory affairs

For our customers in Stockholm-Södertälje regions we are currently looking for competence within Regulatory Affairs.

CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across our customers’ global supply chain. We are looking for people who are curious, creative, and open to new ideas and ways of working. Above all, it is important to be passionate about science and driven to always put patients first.

WHAT YOU’LL DO
As CMC Regulatory Affairs Manager you will provide CMC regulatory and compliance advice on regulatory post-approval submissions and project manage timely submissions of post approval CMC documentation.

You are expected to have broad knowledge of medicinal products, project management, pharmaceutical process engineering, complex Supply Chains in global organizations, and how you contribute to achieving the objectives of the business as well as an understanding of the teams and organization you interact with. The role offers you opportunities to work with global networks.

You will be encouraged to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance.


ESSENTIAL FOR THE ROLE

We would like you to hold a degree in a scientific field (for example, Chemistry, Pharmacy or Chemical Engineering). In addition, you need:
Experience from CMC Regulatory affairs or Regulatory Affairs
Experience from working in the Pharmaceutical industry preferably Pharmaceutical Production, Process Engineering, Quality Assurance or R&D, or experience from Pharmaceutical Agencies or Associations
Practice from working with or contributing to Regulatory CMC submissions including medical products
Project management experience, preferably within CMC Regulatory affairs
To be proficient in both spoken and written English and Swedish

DESIRABLE FOR THE ROLE

You have excellent communication skills, can build constructive networks with colleagues and work collaboratively with customers to achieve optimum outcomes for the business. Strong project management skills and experience of working within a global environment will be invaluable for planning and controlling your own workload as well as effectively managing the expectations of diverse partners. You are comfortable with the use of electronic information and document management tools, and standard Office programs. Background from a LEAN environment would be advantageous.