Regulatory Affairs Information Officer

PLG is seeking a motivated and detail-oriented Regulatory Affairs Information Officer to join our growing life sciences company. In this role, you will ensure global compliance with regulatory requirements throughout the product lifecycle, from development and approval to post-market maintenance, with a specific focus on the accuracy and compliance of product information.

Responsibilities:

Regulatory Affairs Specialist part:

• Ensure regulatory compliance of the entire product lifecycle, market authorization, and post-marketing activities.
• Prepare and submit regulatory submissions (e.g., Manufacturing License Applications (MLA), Marketing Authorization Applications (MAA), and variations).
• Engage with regulatory authorities to ensure that the company meets all legal requirements related to drug approval and compliance.

Information Officer (Informationsbeauftragter) part:

• Ensure the accuracy and compliance of product information provided to healthcare professionals and consumers.
• Review, approve, and update: Patient Information Leaflets (PILs), Summary of Product Characteristics (SmPC), Labeling and Packaging Information, Advertising and Promotional Materials
• Acts as a gatekeeper for all public-facing information related to the medicinal product, ensuring that it complies with relevant regulations (e.g., §74a AMG).

Experience:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree or higher is a plus).
• 5-10 years of relevant experience in Regulatory Affairs, focusing on both the regulatory compliance of medical products and the accuracy of product information.
• Proven experience in the lifecycle maintenance of medical products, including hands-on experience with Marketing Authorization Applications (MAA), Common Technical Documents (CTD), and product labeling.
• Strong familiarity with European Regulatory Authorities and international regulatory frameworks.
• Demonstrated expertise in reviewing and approving product information texts and ensuring compliance with regulations (e.g., §74a AMG).
• Proficiency in regulatory software packages and databases, such as Microsoft Office Suite, Veeva Vault (or comparable EDMS), Lorenz, Trackwise, PromoMat, etc.
• Fluent in English and German, with excellent communication skills—both written and verbal; proficiency in additional languages is a plus.
• Excellent organizational skills with the ability to prioritize tasks and deliver high-quality work in a fast-paced environment.
• Experience in people management or coordination is a plus.