Senior Manager, Regulatory Labeling

Job Description
The Senior Manager, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC, and Rest of World (RoW) labeling. They provide labeling expertise to the Labeling Working Group and other relevant stakeholders, typically carrying out responsibilities with minimal guidance. The Senior Manager leads the development of labeling strategies and is responsible for the management of marketed or pipeline products across the product lifecycle.

A Day in the Life
In this role, a typical day might include:

Managing the regulatory labeling process throughout the product lifecycle.

Leading the Labeling Working Group and managing the development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and RoW labeling. This role manages complex programs with minimal support from the Labeling Director.

Leading the development of labeling strategies through the interpretation of labeling regulations, guidelines, and competitor analyses, and applying them to product situations.

Leading the development of target labeling documents to support the design and analysis plan for clinical trials, with guidance from the Labeling Director.

Leading or contributing to discussions on labeling topics at relevant management interactions.

Effectively communicating labeling rationales to various levels of management to enable decision-making.

Providing labeling expertise on complex issues to stakeholders.

Anticipating Health Authority (HA) perspectives and the broader implications of strategies, proposing alternatives and providing advice to mitigate risk.

Communicating consequences to the product portfolio.

Preparing submission-ready labeling documents.

Maintaining labeling documents in the electronic document management system and relevant labeling trackers as appropriate.

Contributing to the development of the Regulatory Labeling Group through active knowledge sharing and mentoring of junior staff members to build labeling expertise.

Monitoring worldwide regulation changes pertaining to labeling regulations and maintaining the labeling SOP and work instructions. This role may be responsible for leading or contributing to various continuous improvement projects.

What We’re Looking For
This role might be for you if you have the:

Ability to think strategically, assess risks, and propose strategies to manage risk.

Ability to lead Labeling Working Groups to address labeling issues, develop plans of action, and oversee the completion of complex labeling projects.

Expert knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines.

Ability to assimilate clinical and scientific information and present it in a concise manner.

Ability to work independently and use judgment to make decisions and escalate problems appropriately.

Proactive nature to share information with peers and generate discussions to resolve complex issues.

Ability to handle multiple projects and prioritize work independently.

Ability to operate in ambiguous situations and provide functional guidance to others.

Attention to detail and strong word processing skills.

Requirements
To be considered for this opportunity, you must have the following:

At minimum, a Bachelor’s degree (BS) from an accredited college or university in Life Sciences. An advanced degree (Masters, Pharm D, Ph.D, MD or DO) in the field of medicine or science is preferred. Regulatory experience can offset education requirements.

3-4 years of related Biotech or Pharma industry experience, 2 or more of which are in labeling, is preferred.

In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process.

Familiarity with policies and operating procedures in medical safety, regulatory, and/or corporate and worldwide Regulatory Agencies.

Apply Today
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)
$148,300.00 – $241,900.00