CMC Regulatory Affairs Associate

Are you ready to play a key role in shaping the future of medicine? As a CMC Regulatory Affairs Associate in Södertälje, you will have the opportunity to influence every step of drug development, work in a dynamic team, and contribute to groundbreaking innovations that improve patients' lives.

About the Position

As a CMC Regulatory Affairs Associate, you will support product divestitures by preparing and managing regulatory documents, maintaining electronic systems, and collaborating with internal and external parties to ensure compliance and effective information transfer.

About You

Formal Qualifications

We are looking for someone with a basic or associate degree in Regulatory Sciences, Pharmacy, or Pharmaceutical Sciences. You should have experience in Regulatory Affairs or Quality Assurance and possess good IT skills. The ability to work in a team is crucial for success in the role of CMC Regulatory Affairs Associate with us in Södertälje. Your expertise will be central in supporting product divestitures and ensuring compliant product supply.

Desirable Qualifications

It is advantageous if you have a bachelor's degree in sciences, Regulatory Sciences, Pharmacy, or Pharmaceutical Sciences. Basic knowledge of the regulatory application process and an understanding of current regulatory CMC requirements are desirable. A fundamental understanding of the regulations and guidance governing the manufacture of biotechnology products is beneficial, as well as professional skills in Lean methodology and quality risk management.

As One of Us

As an employed staffing consultant with us, you will always receive a competitive salary, vacation, pension contributions, insurance, and access to our collective agreement. We want you to feel good with us, so we naturally offer our consultants wellness benefits and occupational health services. During your employment, you will have a consultant manager responsible for your assignment, ensuring that you thrive in your workplace and supporting you in your professional development.

About Lernia

Lernia is one of Sweden's leading staffing and recruitment companies and operates nationwide. With our extensive network, we offer exciting jobs with attractive employers and brands that help you develop your skills and career, both in the long and short term.

How to Apply

To apply for the position, scroll down to the application form below. Selection and interviews are ongoing, so submit your application today! If you have any questions, feel free to contact consultant manager Hanna Bertilsson via email: hanna.bertilsson@lernia.se (mailto:hanna.bertilsson@lernia.se). To apply for the position, please submit your CV and cover letter via the link. If you have questions, you are welcome to contact consultant manager Hanna Bertilsson via email: hanna.bertilsson@lernia.se (mailto:hanna.bertilsson@lernia.se). No applications are accepted via email.