The position is in Regulatory Affairs department. The primary responsibility for the position is to learn the necessary aspects involved with the preparation of all regulatory submissions including ANDA/NDAs, amendments, annuals reports and safety reports. The individual will maintain the relevant documentation generated for these filings currently established at Avet Pharma Labs Inc.
· Participates in the successful preparation and filing of all regulatory submissions ANDA/NDAs, amendments/supplements, annual reports, labeling etc. with supervision
· Learns techniques to review US Package Inserts, Patient Package Inserts and Medication Guides as and when changes are made internally and to the RLD.
· Learns to check documents for completeness and compliance with regulatory requirements
· Provide administrative and related project support.
· Follows standards for document preparation, timeline development/ management, and procedures required for eCTD format.
· Formatting support for documents to ensure consistency within and between documents and with document templates.
· Responsible for data entry, filing, archiving, and maintenance of submission tracking databases.
· Maintain following regulatory standards
· Perform regulatory research and regulatory intelligence as needed.
· Learns to evaluate and prepare supplements to approved ANDAs and communicating pertinent conditions of ANDA and supplemental approvals.
· Responsible for annual review and evaluation of filed and current documents relating to the ANDA.
· Provide support in reviewing change control documents
· All other duties assigned by Manager.
· Entry Level Position – Responsible to learn and assist with Key Responsibilities.
· B.S. in Pharmacy /Science (or related field) required.
Previous experience in pharmaceutical industry desired.
: Individual must be able to bend, sit for periods of time and reach for files. This job will require some lifting.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs
|Job Category||Regulatory Affairs|