Director, Regulatory Labeling Operations
- Regeneron Healthcare Solutions, Inc (USA)
- Remote - United States
- 7mo ago
- Full-Time
- Remote
...
Regeneron is seeking a Director, Regulatory Labeling Operations to join our team!
In this role, a typical day might include:
The Director, Regulatory Labeling Operations will be responsible for providing oversight to Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks for marketed products as well as products in full development. Oversees the preparation and delivery of submission-ready labeling documents. Manages interface with Manufacturing/Supply Chain, Regulatory Operations, and various labeling vendors (e.g., SPL, translations, QC tool, etc.). Leads or supports labeling content and/or artwork system development and implementation. Supports the creation or revision of labeling SOPs or work instructions.
This role might be for you if you can/have experience:
• Leading Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks, e.g., carton, container labeling, printed package insert, for full development products as well as marketed products.
• Leading and/or advises Packaging Teams to ensure packaging component content and artworks are compliant with internal labeling policies, standard operating procedures and worldwide health authority regulations and guidance.
• Managing Regulatory Labeling Operations Group and provides training and guidance for direct reports.
• Managing relationships with internal stakeholders such as Manufacturing/Supply Chain, Regulatory Operations, cross functional packaging team members, as well as various labeling vendors (e.g., SPL, translations, readability, QC tool)
• Providing labeling expertise to novel packaging design initiatives
• Leading and/or collaborates with internal experts to develop & implement labeling content and/or artwork management system solutions
• Supporting operational labeling deliverables not limited to SPL, EMA translations/linguistic reviews, preparing submission ready labeling documents, proofreading/QC, labeling contributions to periodic reports
• Monitoring worldwide regulation changes pertaining to Labeling
• Supporting the creation or revision of labeling SOPs or work instructions
To be considered for this opportunity, you must have the following:
• Bachelor's degree (BS) from an accredited college or university, preferably in the field of Health/Science OR 10+ years of industry experience
• In-depth knowledge of worldwide Regulatory Agencies, industry practice, packaging manufacturing process, and the drug development process. Familiarity with FDA, EMEA, and international packaging regulations and industry practices for biologic and combination product.
• 10-15+ years of Biotech or Pharma industry experience in regulatory labeling and packaging, and some management experience
• Experience implementing new corporate labeling and/or artwork systems
• Experience managing labeling process initiatives
• Ability to lead/advise Cross Functional Packaging Teams to navigate printed component labeling issues, develop plans of action, and resolve complex issues.
• Ability to work independently and use judgment to make decisions and escalate problems appropriately.
• Ability to handle multiple projects and prioritize work independently for self and direct reports.
• Attention to detail and strong word processing and organizational skill.
#GDRAJobs
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
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