Job Description

• Regulatory Affairs Operations Associate to support submission review, publishing in eCTD format and archiving for ANDAs, NDAs, sNDAs, INDs, DMFs, annual reports and safety reports.
• Technical document preparation for electronic submission such as bookmark, hyperlink and PDF properties.
• 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 and trackers daily.
• Utilize Electronic Submission Gateway (ESG) to submit submissions to FDA centers.
• 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 in identifying solutions.
• Other functional duties as requested by management.

Education:

• Bachelor\xe2\x80\x99s degree

Experience:

• 3-5 years of related professional experience in the pharmaceutical industry with 2 of those years in regulatory affairs registration and publishing management.
• Computer knowledge, problem solving skills, work-ing knowledge of regulatory and drug development processes, technical knowledge, innovative and cre-ative and possesses good judgment.
• Good understand of CTD and US FDA registration requirement.
• Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals. Work in a safe and efficient manner.

Job Type: Contract Pay: $45.00 - $55.00 per hour Ability to commute/relocate:

• Princeton, NJ 08540: Reliably commute or planning to relocate before starting work (Required)

Experience:

• regulatory affairs registration and publishing management: 2 years (Required)
• eCTD submission: 2 years (Required)

Work Location: In person