Regulatory Affairs Manager

Do you want to play a key role in ensuring regulatory compliance and lifecycle management for innovative vaccines? Valneva Sweden is looking for a proactive and detail-oriented Regulatory Affairs Manager to join our team in Solna. 

About us 

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. 

Valneva operates in Austria, Sweden, the UK, France, Canada and the USA with around 800 employees. Valneva Sweden AB has a long history in Sweden and today operates from Solna. 
 
Learn more at www.valneva.com  

About the role  

As Regulatory Affairs Manager, you will manage regulatory maintenance for Valneva Sweden’s products across global markets, including preparing changes and registration applications. You will review packaging materials for Dukoral in collaboration with production, QC, supply chain, marketing, and sales, and ensure medical and promotional information complies with approved texts and guidelines. You will also provide regulatory support for local change cases and other agreed activities, such as distribution products. 
 

Key responsibilities 
 

• Prepare and submit regulatory applications to authorities 

• Lead or participate in projects related to local change cases 

• Communicate authority decisions internally 

• Monitor and share updates on regulatory requirements 

• Maintain high standards of regulatory documentation 

• Ensure consistency between approved documentation and manufacturing/QC specifications 

• Manage registration and license applications for lifecycle and new marketing authorizations 

• Oversee packaging material applications and ensure alignment with approved product information 

• Evaluate regulatory impact of local changes 

• Maintain compliance through SOPs, archiving, and housekeeping 

• Support regulatory activities for distribution products in Nordic countries 

Requirements

• Bachelor’s degree or higher in a relevant discipline (Regulatory Affairs Certification, GMP training, or Swedish/EU regulatory certificates are a plus) 

• Minimum 3 years’ experience in a similar role 

• Strong Microsoft Office skills 

• Fluency in Swedish and English, spoken and written 

• Previous experience in Life Sciences is an advantage 

• Proactive, detail-oriented, and solution-focused 

• Strong interpersonal skills and ability to build relationships 

• High integrity, confidentiality, and ability to work under pressure 

• Excellent prioritization and organizational skills 

Benefits

Employment & benefits 
 
This is a permanent position with a 6‑month probation period. As an employee at Valneva, you will benefit from several perks that support both your health and your development: 

• Competitive salary under the applicable Swedish collective agreement 

• Access to occupational health services 

• Wellness allowance 

• Vaccinations and reimbursement for medical visits and prescription medicines 

• ITP occupational pension 

• Eligibility for bonus and stock option programs 

 
How to apply / Questions 
 
Selection and interviews are ongoing—please submit your application as soon as possible. 
Questions? Contact HR: [email protected]. 

Please note: We respectfully decline contact from recruitment and staffing agencies or suppliers.