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Regulatory Affairs JrAssociate


Novi Beograd
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Job Details

**Position Purpose**

Provide administrative and compliance support within the Regulatory Affairs Team.

Be accountable for regulatory compliance within the area of responsibilities.

Provide support to local Regulatory Affairs Team Members in license maintenance and related activities in a timely manner and support product availability on the market.

**Primary Responsibilities**

Preparation of documentation for HA submission

+ Provide support to local Regulatory Affairs Team Members to collate, prepare and where required create local specific document for HA submissions (registrations, renewals, labeling variations, amendments).

+ Prepare CMC variations for assigned products.

+ Archive documents in coordination with local Regulatory Affairs Team Members.

Work with Pfizer Databases

+ Collate and track information about submissions and approvals of all new/ongoing applications, renewals and variations.

+ Ensure all relevant stakeholders are timely and properly informed.

+ Ensure all local and electronic databases are updated.

Coordination of samples and certificates and other import-related activities

+ Prepare requests for import license of non-registered products.

+ Order, receive and dispatch registration samples and reference standards.

+ Quality check of DP samples and manufacturer's CoA for each Lot intended for import in Serbia, prior to the application for CoA to National Control Laboratory.

+ Perform all necessary activities related to additional labels and control labels.

+ Control monthly reconciliation reports for control label usage and prepare yearly report for HA.

+ Follow up ongoing activities and escalate when necessary.

Administrative and assistant tasks

+ Organize and prepare logistics and traveling for local Regulatory Affairs Team Members.

+ Process accounts, payments and expenses.

+ Organize courier (DHL) shipment.

+ Order and provide administrative documents to internal stakeholders for tender support.

Support of artwork preparation

+ Initiate PAR and artwork preparation.

+ Perform quality check (QC).

Translation activities

+ Prepare back-translation of required documents.

+ Perform quality check for translations where required.

Inspections Audits

+ Provide support for all audits under Medical Director / Platform Head (Regulatory /Safety) Accountability, including audit corrective and preventive action plans (CAPAs).

+ Audit preparedness.

+ **Technical Skill Requirements**

+ High level of proficiency in both local and English language (written and spoken)

+ IT knowledge, excellent MS Windows and MS Office user skills

+ Spreadsheet management

+ Familiarity with the use of databases

+ Basic knowledge in the field of regulatory affairs, obtained through education or relevant experience

**Qualifications (i.e., preferred education, experience, attributes)**


University degree (preferably pharmaceutical science)


Capacity to define priorities according stakeholders needs

Accuracy and high level of attention to detail

The ability to work well within a team and across lines

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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