Regulatory Affairs Associate II

Job Description

Job Description

Responsible for supporting business registration process, for eCTD submission, electronic document lifecycle, system validation and to review regulatory affairs submissions documents electronically to ensure all Regulatory requirements are met.

Major Accountabilities

Support review and approval of OPDP submission documents such as Important Safety Information (ISI) electronically and / or manually.

Create and maintain Submission ready documents such as 2253 form, cover letter and other applicable.

Support submission review, publishing in eCTD format and archiving for ANDAs, BLA, etc.

Support technical document preparation for electronic submission such as bookmark, hyperlink and PDF properties.

Support ensuring the compliance and deliverables of applicable regulations, guidance requirements, such as documents formats and named in accordance with FDA, ICH guidelines & internal guidelines / SOPs.

Engage in life cycle management of submission documents (if necessary) to ensure document integrity in DMS and publishing tool.

Track and monitor metrics, maintains submission tracking tool in system.

Utilizing technical skills for learning new features / applications of software which can support to improve the efficiency and complexity.

Demonstrates robust communication and listening skills; must be able to effectively identify opportunities and challenges and partner with co-workers for solutions.

Other functional duties as requested by management.

Key Performance Indicators

Support system product submission process through the accurate and timely completion of assignments.

Support submission registration tracking in management system.

Support submissions review, publishing, and archiving.

Support timely approval of promotional materials through accurate and timely ISI review.

Comprehensive understanding eCTD regulatory knowledge. General knowledge of other related disciplines.

Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

Performs duties with the highest ethical standards, delivering only high-quality, compliant solutions.

Reliable and transparent with all activities in a timely manner.

Demonstrate cordial and respective service to all customers.

Veeva system knowledge is a plus.