Regulatory Affairs Coordinator

**Company Description**

The Regulatory Affairs Coordinator is responsible for the handling of the label management, for the management of the Regulatory Affairs budget, reporting topics and providing support in the handling of Medical Devices within Regulatory Affairs. Furthermore he/she is responsible for generally supporting the Regulatory Affairs department according to the product responsibility list:
He/She is responsible for delivering successful regulatory submissions and approvals, to ensure that products comply with local regulatory requirements and to support the commercialisation of products through participation in local brand teams and QA product release.

**Key responsibilities**:

- Label management
- Preparation, proof-reading and approval of artwork for products (drug products and medical devices) of AbbVie AG
- Contact with labeling center, manufacturing sites, local QA and/or Demand Manager and use of AMS / HUB regarding implementation of new artwork versions and preparation for publication.
- Publication of new and revised product information (Arzneimittelinformation) on HCI solution platform (which will support Swissmedic Refdata publication platform)
- Ensures on-time label implementation and publication.
- Administrative tasks within RA (update of various tracking lists, online systems etc.)
- Contact with Global Label Group, Swissmedic, WE A&AS with regards to label implementation
- Support of all commercial functions regarding label information
- Regulatory product responsibility according to product responsibility list
- Maintaining and updating marketing authorisation of licensed products (variations, label changes, renewals etc)
- Ensure accurate compilation, management and tracking of submissions
- Review and approval of promotional and non-promotional material
- Handling of product safety concerns with Swissmedic, support of related functions (PV, QA, Medical and others) in case of product actions (product recalls)
- Submission of PSUR and RMP
- Contact with authorities (Swissmedic) and AbbVie Area & Affiliate and global RA
- Staying updated with Swiss regulatory requirements, authority organization, processes and environment
- Support for Regulatory Medical Device handling
- Regulatory budget:

- Account assignment of the invoices
- Issuing Purchase Orders and Invoices (ACR) in SAP
- Maintain the Regulatory Department Budget excel sheet
- Build Accruals on a monthly basis
- Regulatory Contracts:

- Collaboration with Purchasing to draft contracts
- Maintenance of contracts

Employee Relations:

- Ensure accurate reporting to the Regulatory Affairs Director and distribution of relevant information within the regulatory team and to the employees of the different functional areas.

Headquarter relations:

- Ensure accurate, on-time interaction with the RA colleagues where support is needed. Ensure accurate, on-time information to RA colleagues regarding submissions and approval as well as in case of request.
- Ensure accurate, on-time interaction with WE A&AS and global RA where support is needed.
- Ensure accurate, on-time information to WE A&AS regarding submissions and approval (e.g. AbbVie Connect) as well as in case of request.

SOP:

- Ensures compliance with all applicable local and global processes and procedures
- Application of Good Documentation Practice

**Qualifications**
- Degree in Pharmacy, Life Sciences or similar preferred
- 5+ years of experience in a similar role within a Regulatory Affairs environment in the pharmaceutical industry
- Comply with all relevant Regulatory and Quality policies and procedures to ensure the Regulatory and Quality objectives of the business are met.
- Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures and work practices with the intent of preventing or minimizing accidental exposures to self, colleagues and/or the environment
- A desire to contribute to the overall success of the business
- A team player with an holistic approach to working in a matrix environment
- Well organized and detail-oriented with a proven ability to meet deadlines and achieve goals.
- Good communication skills
- Business fluent in German and English, French is an asset

**Additional Information**

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