MSD Regulatory Affairs Manager m/w/d 

Germany, Bavaria, Munich 

654978562

Job Description

Major Activities (may not be limited to):

• Manage and support timely and correct submission and approval of assigned New Marketing Authorization applications (MAA) and Supplemental Marketing Authorization applications (e.g. new indications, variations, renewals) in close cooperation internally with multiple departments on national, regional, and global level and close interaction with relevant regulatory authorities
• For new MAA and new major indications, design and implement local action plans to ensure proper product launch in line with local project plans
• For new MAAs and major indications manage and implement Early Access Programs (EAPs)
• Ensure timely and correct local implementation of all relevant approved Marketing Authorization applications in compliance with all applicable regulatory regulations as well as internal national, regional and global processes with regard to high quality German translation of the approved Product Information and artwork implementation and update of all relevant internal regulatory databases and archives, internal and external websites and compendia
• Support the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with RAE Liaison, and other internal stakeholders
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed
• Participates in establishing and maintaining of relevant SOPs to secure that the current regulations are complied with
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance

Qualification:

• Master’s degree in Pharmacy or other a relevant scientific discipline or equivalent
• Minimum of 5 years’ experience in a Regulatory Affairs Department, experience with relevant aspects of Regulatory Affairs activities, Regulatory Agency contact and experience in supervising others
• Familiar with local and EU legislation procedures and guidelines governing medicinal products and medical devices
• Experience in the translation and implementation of product information texts as well as with Market Access strategies
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to internal and external stakeholders
• Fluent in German and English
• Strong project management skills, including the ability to prioritize tasks, manage timelines, and deliver high-quality results under tight timelines
• Meticulous attention to detail, ensuring accuracy in regulatory documentation and compliance with all relevant standards and regulations
• Proficient in working in a modern digital and paperless environment utilizing MS Office tools and collaboration platforms and systems for documentation, analysis, and reporting, enhancing efficiency in regulatory processes
• Client-oriented approach and excellent relationship-building skills

Current Contingent Workers apply

No Travel Required

Not Indicated