Pfizer Regulatory Affairs Associate in Herzliya Pituach, Israel
The RA (Regulatory Affairs) Associate role supports Regulatory Affairs related activities in compliance with the current Pfizer's SOPs, Policies, Guidelines and local procedures & regulations
Primary Responsibilities :
Handling new Drugs and line extensions process:- Obtaining licenses and marketing approvals of new products and line extensions. - Understanding the registration process in Israel, appreciate at what stage the Application is and takes appropriate action to keep the process on track.- Preparing and/or monitoring formatting of registration files in accordance with the Israeli MOH requirement and guaranteeing their quality.
Maintaining registered products - Keeping all licenses current and renewed at designated compliance. - Handling variations approval according to Pfizer and Local regulations procedures - Managing Medical Information queries responses - Provide registration input into product returns and destruction process- Managing the transfer of licenses to Pfizer following integration or acquirement of a pharmaceutical company- Keeping valid import licenses for all Pfizer Pharmaceuticals Israel products
Supervising and supporting distributors- Support import, packaging, 1st batch process and updating distributors with new procedures and/or requirements as appropriate. - Supervise distributors working practices and conducting review visits on a periodic basis as needed. 2. LPD & PIL Preparation
According to REG -013. Package Design Revisions
Preparing packaging material for new products and updating packaging material for old products to be in line with MoH and Pfizer requirements.
Receiving approval from Appointed Pharmacist for all new and updated packaging materials.
Updating Pfizer Israel distributors on new packaging material and/or changes to packaging material of Pfizer products for both common and dedicated products and verifying their conformation
Distributing the correspondence documents between Pfizer and MoH, regarding package design revisions to the relevant personal.
Updating Pfizer Manufacturing sites (including contracted sites) on updates to packaging materials for dedicated products.
Updating RA Director on correspondence documents between Pfizer and MoH, regarding package design revisions.
Filing and storage of relevant documents between Pfizer, MoH and Pfizer distributors regarding package design revisions in the appropriate folders and updating the necessary files in electronic format.
Acting as an intermediary between Pfizer and MoH during the approval process and in cases of revision demands from MoH in order to ensure that all of MoH demands are responded to adequately.4. Update of RA Database
Update the relevant RA Databases as required.5. Correspondence
Responding to inquiries & demands from MoH, PPIL Business Units, Pfizer distributors, Pharmaceutical Manufacturers' Association and other departments or transferring them to relevant personnel.
Maintenance of the folders related with products and correspondences6. Medical Information
Responding to customer inquiries effectively and recording relevant information about the inquiries.7. Product quality
Managing Product quality issues in accordance to the MoH regulation, Pfizer's SOP's and Work Instructions8. CTA responsibilities
Liaise with clinical research project managers to seek to understand clinical research programme.
In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries.
Ensure timely communication of any GCP breaches, or actions taken for safety reasons.
• Experience with CTA submission
• Fluent in both Hebrew and English (written and spoken)
• Well-organized, independent
• Strong interpersonal/communication skills
• Attention to details
• Analytical thinking
• Flexible/Ability to adapt to changes
• Good PC skills
• Ability to learn quickly
• High ethical standards
• Team Player
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.