EDUCATION:

• Degree in Pharmacy, Life Sciences, or related discipline

EXPERIENCE:

• Minimum 5 years of regulatory affairs experience in the pharmaceutical industry, ideally in women’s health or related therapeutic areas
• Demonstrated knowledge of German and EU regulatory frameworks, including national and European procedures (DCP, MRP, CP)
• Experience interacting with German and Austrian regulatory authorities and serving as a Drug Information Officer

SKILLS:

• Fluency in German and English (written and spoken) is essential
• Proven track record in regulatory submissions and lifecycle management
• Excellent organizational, problem-solving, and communication skills
  Ability to work independently in Germany while collaborating effectively with cross-border teams in a matrix organization.

JOB PURPOSE

To ensure compliance with local and international regulatory requirements are maintained locally.

KEY DUTIES AND RESPONSIBILITIES

Support all local regulatory activities for the company’s product portfolio in Germany and Austria including:

• Act as primary liaison with German health authorities (BfArM, PEI) and local industry associations
• Manage final preparation and submission of regulatory documentation (MAAs, variations, renewals, PSURs, RMPs, etc.) in Germany and Austria
• Preparation, update and review of national translations of Product Information (PI) documents throughout the life-cycle of the medicinal product.
• Collaborate with cross-functional teams (Medical Affairs, Pharmacovigilance, Quality, Commercial) to ensure compliance and support product launches.
• Monitor and interpret German, Austrian and EU regulatory developments, communicating impacts to key global and local stakeholders
• Maintain accurate regulatory documentation, databases, and trackers in line with local and global guidelines.

Undertake the role of Drug Information Officer, including:

• Provide commercial support and ensure compliance with local promotional material, advertising regulations and all Drug Information related activities.
• Provide review and approval of product information/Artwork

As required, act as the local person responsible for pharmacovigilance (LPPV).