Regulatory Affairs Intern Job (Moscow, Russia)

Description

Janssen, Pharmaceutical Companies of Johnson & Johnson Family of Companies, is looking for a Ragulatory Affairs Intern.

Overview:

1. Product life cycle management (variations submissions and approval incl. new indications, new manuf. sites etc.)

2. Regulatory compliance: CCDSs timely submissions and tracking

3. Reagents and materials purchase for the purposes of sample expertise. Handling HA permissions for standards, reagents and samples import

Key Job Activities:

Product life cycle management (variations submissions and approval incl. new indications, new manuf. sites etc.)
- Preparation of variation dossier for submission according to MoH requirements
- Execution and follow-up of all stages of variation approval process, starting from dossier submission up to variation approval, including package materials and Package Insert leaflet preparation, technical document preparation, pharmaceutical expertise issues, communication with HA, etc.
- Communication with regulatory contacts in HQ and GRA for obtaining necessary documents and materials, negotiations in case of any specific cases/issues.
- Ensure that product information and packaging materials are updated with the most recent variations/CCDS and local requirements at any time.
- Co-operation with BUs and SCD in terms of existing products out-of-stock prevention

Reagents and materials purchase for the purposes of sample expertise. Handling HA permissions for standards, reagents and samples import Order of standards, reagents and samples in accordance with company procedures
- Reagents and materials orders, and receipt follow up
- Preparation of the dossier to apply for import permission
- Receiving of HA permission, checking for possible mistakes
- Collaboration with logistic specialist on the questions of standards, reagents and samples import

Other Job Activities:
- Participation in the global regulatory affairs Workstreams managed from HQ
- Act in compliance with company SOP’s and HCBI/HCC procedures (local SmPC internal approval SOP, etc)
- Communication with local HA, Regulatory Bodies
- Maintenance of the regulatory databases and files
- Provision of the regulatory reporting to the GRA on the regular basis (IRS-forms, SPS database, WRAT, etc)

Qualifications

Education: High pharmaceutical, chemical, medical, biological

Primary Location:Europe/Middle East/Africa-Russia-Moscow-Moscow
Organization: J&J LLC Russia (8431)
Job Function: Regulatory Affairs
Job Segment: Intern, Medical, Regulatory Affairs, PLM, Law, Entry Level, Healthcare, Legal, Management

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