Senior Manager Regulatory Affairs

Your tasks and responsibilities

• Manage Regulatory Affairs applications to Competent Authorities such as New Marketing Authorisation applications, renewals, variations, notifications, exemptions or similar;
• Support the company in Regulatory Strategy concerning current and new products in close collaboration with Business Development;
• Handle translations, local variations, notifications, exceptions etc for products where acts as local representatives
• Review and approval of promotional material
• External handling of Product Information such as catalogue texts (FASS, Felleskatalogen, Pharmaca Fennica, etc;
• Coordinate Artwork (AW) processes such as development of new AW for  products and multilingual Nordic packages
• Perform RA intelligence screening
• Ensure that any additional requirements imposed on certain products by national law are implemented
• Continuously improve work process, productivity and accuracy of regulatory function

Required qualifications

• University Degree in Life Sciences such as Pharmaceutical Science or similar
• At least 5 years professional experience in Regulatory Affairs
• Experience of leading projects and cross-functional teams
• Experience of due diligence and compiling of regulatory dossiers
• Excellent communication skills and fluency in Swedish and English, both verbal and written. Strong writing, reading and reviewing skills are necessary. Knowledge of any other Nordic language would be an asset

Personal capability requirements

• Proactive self-starter, solution oriented, keen to maximize opportunities and open-minded and willing to adapt to changes
• Highly self-motivated and able to drive activities
• Strategic thinking
• Strong team player, with the ability to work effectively in team setting and interaction with people of different seniority and functional backgrounds

City

Stockholm, Danderyd