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Associate, RA - Publication

Application Deadline: January 5, 2019

Location: Schaumburg, ILLINOIS, USA

Job Summary / Overview:

Responsible for the support of Pre and Post approval regulatory affairs activities as directed by the Associate Director which may include: Drug listing, annual reports, adverse event reports, electronic assembly and publication of FDA submissions, labeling, advertising and promotional material review and database management.

 

Success in the role is measured on:

  • Timely and accurate pre-submission review, formatting and electronic entry of FDA Submissions including ANDA’s, 505(b)(2)s, Amendments, Supplements, Annual Reports, DMF updates and Labeling changes according to regulatory guidelines.

  • Timely and effective support and troubleshooting of the Electronic Submission System.

  • Assist in MSDS preparation so that at the time of launch of new products MSDSs are available and that MSDSs are maintained over the life of the product.

  • Timely and accurate data entry into database systems.

  • Any additional responsibilities as assigned by Scientific Affairs / RA Operations Management.


Key Duties & Responsibilities:

  • 75% - Pre-submission review, formatting and electronic entry of FDA Submissions including ANDA’s, 505(b)(2)s, Amendments, Supplements (CBE-O, CBE-30, Prior Approval), Annual Reports, DMF updates and Labeling changes.

  • 10%- Support RA Tracking database entry and audit, maintenance, troubleshooting and assist with validations of the Electronic Submission System. Maintenance of the eSubmission Training Manual.

  • 10%- Analysis of Change Controls and determination of submission categories and prerequisite documentation requirements.

  • 5%- Preparation of Material Safety and Data Sheets for all drug products. Support Adverse Event reporting.

  • 5% domestic and international travel may be required.


Knowledge or Experience:

  • Regulatory Affairs or Quality Affairs experience preferred.

  • Extensive experience in the use of PC-Based word processing software, databases and spreadsheets (Microsoft Office Word and Excel preferred), and Adobe Acrobat.

  • Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML – Compliant schema.

  • Experience in computer validation, database auditing.


Minimum Qualifications / Experience:

  • Strong planning and organizational / project / workload management skills.

  • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects.

  • Ability to prioritize projects independently as well as experience working in project teams.

  • Ability to drive projects to completion with minimal oversight.

  • Solid interpersonal (verbal and written) communication skills at all levels.

  • Thrive in, and be able to work in, a fast paced entrepreneurial environment with broad responsibilities.

  • Have a passion for quality and an impeccable detail orientation.


Education / Certifications:

  • RA or QA experience preferred. Science background degree preferred (Chemistry, microbiology/biology, pharmacy, premed, nursing, life sciences).


 

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

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