Regulatory Affairs Specialist/German Speaking

Our global biopharmaceutical client is currently undergoing a review and compliance drive of all their product labelling. They are looking for an experienced regulatory affairs specialist to support them, who has extensive experience in global market labelling requirements.

Responsibilities:

* Responsible for the generation and maintenance of CH and international product labelling texts and mock-ups, compliant with current product CCDSs and in accordance with regional or local Health Authority requirements for the assigned Region.

* Responsible for the timely provision of all required labelling documents needed by the Region for submissions to HAs where product label is affected.

* As a Subject Matter Expert, responsible for continuously collecting, understanding and communicating HA requirements and opportunities related to product labelling for new drug applications as well as licensed products for the assigned Region.

* Responsible for the implementation of new and updated Company Core Data Sheet's (CCDS's) of CSL Behring products in CH and international labelling of the assigned within the set timeframe.

* Interacts with relevant stakeholders like the CCDS owners, the points of contacts in the Region boundaries, and local commercial organizations, as applicable.

* Ensures compliance with the regional/country specific regulatory requirements and procedures governing leaflets and labelling (ie general regulations, readability guideline, health authority templates, etc.).

* Ensures compliance of region/country specific labelling texts with the CCDS

* Tracks region/country specific deviations from the CCDS and brings these deviations to the attention of the CCDS owner for decision making.

* Ensures that printed packaging materials are updated subsequent to labelling changes.

* Arranges translations of product labelling texts as required and in collaboration with local offices/third parties.

* Plans and manages readability user tests, as needed (EU specific).

* Maintains labelling databases and systems (PAS, GRDC), as needed.

* Contributes to an efficient and compliant end-to-end global labelling process.

* Participates in projects to implement and improve labelling processes and systems.

Requirements:

* Master in pharmacy or chemistry or equivalent experience.

* Extensive experience in the (bio)pharmaceutical industry required.

* Knowledge of global product labelling regulations, guidelines and regulatory processes for product labelling.

* Previous experience of biopharmaceutical products.

* Previous experience of compiling CCDS and CCSI required.

* Strong interpersonal, oral and written communication skills.

* Strong organization and planning skills.

* Ability to work in cross-functional and international environment.

* Detail- and goal-oriented, quality conscientious, and customer-focused.

* Ability to adhere to strict project timelines, strong team player.

* Fluent written and spoken English is required; fluent German conversational skills required.

Please apply now for more information!