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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Assistant Regulatory Affairs

Ludwigshafen am Rhein, Germany Req ID 2205952 Category Administrative Services Division AbbVie

 

 Your tasks

• Organizational and administrative routine activities of the  Regulatory & QA department

• Administrative support of parallel sales and parallel import displays

• Electronic and paper-based storage and archiving

 

This includes:

• Independent handling of correspondence in German and English

• Support for meetings, business trips and external events using  AbbVie systems: − Support of meetings - Assistance in the organization of appointments, invitations, room bookings , catering, document preparation and logging, follow-up meetings

− Organization of business trips (travel and accommodation) and travel expense reports, mediation of course bookings / seminar registrations

− Tracking of all department-relevant appointments

 

• Edit mail / mail

 

− Management of incoming and outgoing mail for the entire department

− Sorting and distribution of documents for mail, scans and emails from the authorities

− Submission, Archiving Regulatory Correspondence

• Parallel sales / import - management and documentation of incoming and outgoing samples

 

- Internal follow-up to  ensure timely  response to submission

− Support in the preparation of applications for authorisation

− Creation of status reports and measured values

− Tracking the SmPCs of AbbVie products on government websites  and reporting any discrepancies

• Independent storage/archiving

 

- Paper-based storage in data rooms with maintenance of folder structures, marking

- Responsible archiving of the paper stock in digital form and transfer to external archives

• Other

 

− Quality control of all internal RA databases

− Documentation of training and further education measures for the entire RA department

- Manage the "list of absences" (holidays, illness and other absence dates) of the RA department

− Management of personnel, address, telephone and inventory lists

− Procurement of all office equipment (hardware and software, office supplies)

− Request for all technical services (maintenance, transport, repairs,  etc.)

− Other administrative support as needed


Prerequisite(s):

• Training in the commercial sector or comparable training with appropriate experience

• Excellent german language skills (mother tongue or equivalent)

• English language skills (B2 or better)

• Independent and reliable way of working

• High sense of responsibility

• Strong ability to work in a team

• Very high service orientation

• Knowledge of Microsoft standard software

• Professional experience in pharmaceutical, ideally with a focus on regulatory and/or quality/complaint management

• Experience with parallel sales and import

• Knowledge of GxP regulations

• Experience in archive management/archiving

Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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  • Administrative Services, Ludwigshafen am Rhein, Rhineland-Palatinate, GermanyRemove

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