The Regulatory Affairs Labeling Operations Sr. Manager is responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products as well as products in full development.
In this role, a typical day might include the following:
- Lead the development, revision, preparation and internal approval of packaging artworks e.g., carton, container label, printed package insert, for assigned development products as well as marketed products. In-depth understanding of industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling. Interpret labeling regulations and mentorship, determining company impact and providing direction as appropriate.
- Provide in-depth expertise at relevant department meetings and relevant cross functional teams.
- Lead packaging team to ensure packaging content and artworks are stays in sync with internal labeling policies, standard operating procedures and worldwide health authority regulations.
- Contribute and manage Annual Reports for assigned products.
- Maintain and supervise packaging artwork lifecycle and documents in appropriate labeling repository and electronic systems.
- Manage and review preparation of SPL
This role might be for you if:
- You have in-depth knowledge of worldwide Regulatory Agencies, industry practice, packaging manufacturing process, and drug development process, including. FDA, EMEA, and international packaging regulations and industry practices for biologic and combination product.
- You can drive the development of department strategy, operational objectives, and matters of significance.
- You enjoy resolving highly sophisticated issues where the analysis of situations or data requires an in-depth evaluation of intangibles or situations with minimal precedent
- You have acted as a subject matter expertise to develop innovative business solutions. Serves as an advisor, mentor, internal consultant, and/or helps drive new initiatives
To be considered, we expect you to have at a minimum Bachelor's Degree and 8+ years of proven experience where 6+ years should be focused on Regulatory Labeling.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)