Sr. Associate, Regulatory Affairs, Labeling Sagent Pharmaceuticals
THIS JOB HAS EXPIRED Job Title:
Senior Associate, Regulatory Affairs (Labeling)
Manager OR Associate Director, Regulatory Affairs
Job Summary / Overview:
As directed by the Manager and Associate Director, responsible for supporting the Labeling Team in all aspects of label development (including labeling for regulatory submissions and commercial products) to ensure accuracy related to current text copy and marketing selected design elements. Includes development, editing, and critical review of label copy, support managers in the maintenance of labeling regulatory / quality systems, and updating and managing SPL files.
Success in the role is measured on:
- Formatting and editing label copy in accordance with FDA guidelines and regulations
- Meet deadlines and goals in a timely manner with the highest degree of accuracy and quality in work.
- Ability to work within a flexible framework to meet all regulatory requirements and CMO and business requirements where ever possible.
Key Duties & Responsibilities:
- 60%- Execute activities revolving around shifting labeling priorities including label copy development, proofreading and updating based on partner or FDA requests in an accurately and timely manner. Prepare and critically review labeling files for labeling at all stages of the development life cycle (including submission, deficiency, launch and commercially available labeling) and understanding unique requirements at each phase. Interface with CMO?s and internal stakeholders to create and update label copy for FDA submissions or to respond to deficiencies or RLD updates.
- 20% - Review, maintenance, management and version control of SPL files for drug listing, submissions, establishment registrations etc.
- 10%- Support Managers in maintaining quality systems for labeling (barcode assignments, NDC assignment, label master index, change controls, document versioning, file management etc.)
- 10% - Support of team in accomplishing continuous improvement objectives. Identify process improvements and update SOP?s, work instructions and checklists accordingly.
Knowledge or Experience:
- Extensive experience in the use of PC-Based word processing software, databases and spreadsheets, including Microsoft Office Word and Excel, Adobe Acrobat and Illustrator.
- Knowledge of SPL creation and Drug Listing submissions, regulations and guidances.
- Knowledge of GMP and labeling regulations.
Minimum Qualifications / Experience:
- 4 or more years of direct pharmaceutical industry experience OR solid equivalent experience working in a cGMP and/or FDA regulated environment Preferred.
- Experience with preparing SPL files, label development, or regulatory submissions (labeling) strongly preferred.
- 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.
- Formal project management skills a plus
- Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry a plus.
- 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:
- Bachelor?s degree or higher OR equivalent work experience preferred. Journalism, English or Science degree preferred (Chemistry, microbiology/biology, pharmacy, premed, nursing).
||1901 North Roselle Road |
Schaumburg, IL 60195
THIS JOB HAS EXPIRED