Senior Pharmaceutical Affairs Manager

This is a fully remote position, open to applicants in Germany.

📋 Description

• Serves as the primary local contact or deputy local contact for relevant authorities in Germany.

• Functions as the deputy Information Officer.

• Acts as the deputy GDP Responsible Person in accordance with section 52a of the German drug law.

• Assists in local internal and external audits as well as regulatory inspections, including CAPA.

• Develops and reviews GxP-related local governance documents within the RA and QA sectors.

• Evaluates and approves both promotional and non-promotional materials.

• Keeps the local quality manual up to date.

• Maintains and enhances local GxP training oversight for staff in Germany and Austria.

• Aids in product recalls and mock recalls.

• Manages and processes change controls.

• Oversees and processes deviations.

• Coordinates local distribution efforts at the interface with EU distribution and local distributors.

• Contributes to EU regulatory activities and inquiries, such as health authority requests and regulatory intelligence.

• Supervises the EU end-to-end labelling process.

• Coordinates local tasks related to EU labelling change procedures and other regulatory lifecycle management activities.

• Conducts local commercial artwork proofreading and handles commercial artwork requests and approvals.

• Oversees the publication of the SmPC (Fachinfo Service) and other publications (e.g., Rote Liste).

⛳️ Requirements

• Over 7 years of experience in the GxP/Regulatory field, ideally in affiliate environments.

• Proficient in both German and English.

🏝️ Benefits

• Equal opportunity employer.