Job Description

Job Details:

Position: Regulatory Affairs Associate II

Location : Princeton, NJ

Duration : 12 months

Pay : $50/hr - $54/hr on W2 without benefits

Job Purpose

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.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,

national origin, disability, or status as a protected veteran.

IMPORTANT NOTICE: For California Applicants:

Pursuant to the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Los Angeles Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance, qualified applicants will be considered for assignment with arrest and conviction records. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, meet client expectations, standards, and accompanying requirements, and safeguard business operations and company reputation.

Name : Ammar Bin Anis

email: ammar@ustechsolutionsinc.com

Internal Id : 25-38991

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