• Work with the appropriate electronic systems soon after a new safety and

indication/efficacy information becomes available or the content of the CCDS may

change.

• When approved, work closely with appropriate electronic systems (e.g. AMS) and

Label centers to get labels developed, approved and implemented as per the required

timeframe.

• Work closely with GLM in order to anticipate any back order of the products on the

market by ensuring artwork readiness.

• SmPCs: When approved, work closely with appropriate service provider (Rote Liste

GmbH) to have SmPCs developed, approved and published.

• Patient information leaflets for blind and partially sighted patients: When approved,

work closely with appropriate service provider (Rote Liste GmbH) to make suitable

leaflets available.

• Observe GMP rules for documentation in the described labeling processes.

• Where appropriate, activities to have information published in relevant drug

compendiums (e.g. Rote Liste, Gelbe Liste, Gelbe Liste Identa).

• Contribution to revision of labeling and other SOPs.

• Contact for labeling related audit questions.

Required Education / Knowledge / Experience

• Degree in Pharmacy, Life Sciences or similar

• Several years regulatory experience or in a related area in healthcare industry

• Project management and strategic communication

• Excellent German language skills at native level

• Good English language skills

Salary: The position is remunerated with Tarif E13K.