MSL(Medical Affairs&Regulatory affairs) (m/f/d)

Company Overview
The company is committed to researching and developing treatments for rare diseases. It strives to deliver high-quality medications that enhance the health and well-being of patients. As a prominent player in the orphan drug sector, the company collaborates with various partners, including its headquarters in Japan, to expand its business.

Job Responsibilities
・Discuss and negotiate with Krankenversicherung.
・Discuss with Key Opinion Leaders (KOLs).
・Create and review marketing materials and slides.
・Support the creation and review of sales materials, and assist with market activities such as preparing for and attending congresses.
・Coordinate KOLs in collaboration with sales teams.
・Support and guide clinical trial project development.
・Prepare literature bulletins for approved and developing products.
・Process medical and scientific inquiries and prepare draft responses.
・Provide support to the Information Officer.

Regulatory Affairs
Develop and update regulatory SOPs; initiate the signature flow and collect required signatures.
Conduct regulatory writing and regulatory submissions (in English and/or German) to EMA, MHRA, and other Health Authorities.

・Including support for AMNOG dossier
・Compilation and publishing of regulatory documents in eCTD format
・SmPC updates
・Filing of variations
・Use of EMA and MHRA submission systems

Perform Quality Control (QC) of regulatory documents, including developing QC checklists, execution, and project management.
Plan and update project-related timelines to ensure deliverables are met.

Other Responsibilities
Support tasks related to Sales and the Information Officer.

Job Requirements
Capable of handling multiple tasks simultaneously
Proficient in English at a business level (reading, writing, and speaking)
Experience in creating manuals and procedures is a plus

Benefits
A flexible work environment
Opportunities to gain diverse experiences