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Regulatory Affairs Specialist

2 months ago

Somerville New Jersey, United States VCLS Full time
{"title": "Regulatory Scientist", "description": "About VCLS

VCLS is a leading provider of regulatory services to the life sciences industry. Our team of experts is dedicated to helping clients navigate the complex regulatory landscape and bring innovative therapies to market.

The Opportunity

We are seeking a highly skilled Regulatory Scientist to join our team. As a Regulatory Scientist, you will be responsible for designing and implementing regulatory strategies for clients, crafting and reviewing regulatory documents, and providing expert advice on regulatory matters.

Key Responsibilities
  • Partner with clients to design and implement regulatory strategies for the development of new drugs and/or combination products.
  • Craft and review regulatory documents to the highest standards, compiling dossiers for FDA and global submissions.
  • Advise clients on regulatory strategy and submissions based on the latest regulatory agency guidelines.
  • Effectively manage multiple projects, keeping teams and clients informed with clear communication and established timelines.
Requirements
  • A passionate regulatory affairs professional with a proven track record in eCTD submissions and a deep understanding of health authority interactions, regulations (21 CFR, FDA, ICH), and application processes.
  • BS/BA in Regulatory Sciences or Life Sciences.
  • Embody our core values – People, Innovation, Passion and Excellence.
  • Possess a meticulous eye for accuracy and strong organizational skills.
  • Thrive in a collaborative environment and demonstrate excellent communication skills.
What We Offer
  • A dynamic and collaborative work environment.
  • The opportunity to work with a diverse range of clients and projects.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Professional development opportunities, including training and education programs.
About VCLS

VCLS is a proud equal opportunity employer and values the unique contributions of all individuals. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

", "lang_code": "en-US"}