Manager, Regulatory Affairs, Labeling Sagent Pharmaceuticals
Associate Director Regulatory Affairs
Job Summary / Overview:
This role is primarily responsible for managing the development of labeling and managing key labeling systems and processes to support labeling development and approval at all stages of the product lifecycle.
Success in the role is measured on:
- Ensuring all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products Driving measurable efficiencies and continuous improvements in the labeling processes.
- No reworks, delays in launch or commercial availability or quality/regulatory impacts (recalls, etc.)
- Ability to understand and interpret regulatory requirements, and translate this understanding into solid decision making.
- Ability to work within a flexible framework to meet all regulatory requirements and CMO and business requirements where ever possible.
Key Duties & Responsibilities:
- 45% - Develop submission, launch and post approval commercial labeling in accordance with ANDA project goals, FDA requests or commercial/business needs. Ensure timely execution of shifting labeling priorities to balance all objectives and ensure all project timelines are met. Proofread all types of label copy at all development stages, final label copy, to ensure accurate labeling. Review labeling to ensure all regulatory and GMP requirements are met. Provide project support and manage labeling development process.
- 25% - Manage the creation and routing of Change Requests for final approvals, label master index updates, and file management for labeling files
- 10% - Develop and maintain quality systems used in support of label development processes, including Label Master Index, Change Controls, File Management, NDC assignment, Barcode creation and maintenance.
- 10% - Manage projects to meet established objective while ensuring deadlines are maintained
- 10% - Develop and implement process improvements in label development and label maintenance to ensure continued operating efficiencies.
Knowledge or Experience:
- Understanding of the labeling lifecycle and direct pharmaceutical labeling experience
- Understand context and content of label development
- Proficiency in proofreading and impeccable attention to detail.
- Solid command of GMP regulations and labeling regulations required.
Minimum Qualifications / Experience:
- 5 or more years of direct pharmaceutical labeling experience OR solid equivalent experience in cGMP environment (manufacturing preferred) OR quality OR regulatory submission.
- Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
- Ability to prioritize projects independently / Experience working on project teams and leading teams
- Ability to drive projects to completion with minimal oversight.
- Solid interpersonal communication skills (written and verbal) at all levels.
- Drive, Motivation and Initiative to troubleshoot and problem solve
- Supervisory experience.
- Formal project management skills
- Flexibility and strong negotiation skills
- Thrive in, and be able to work in, a fast paced entrepreneurial environment with broad responsibilities
- Possess a broad career progression including experience in multiple departments in pharmaceutical, drug development or manufacturing industry
- Have a passion for quality and an impeccable detail orientation
Education / Certifications:
- College degree required. Science background degree preferred (biological, chemistry, pharmacy, premed, nursing). Will also consider English or journalism.
||1901 North Roselle Road |
Schaumburg, IL 60195