About VCLS Are you a passionate regulatory professional eager to make a difference in the healthcare landscape? At VCLS (formerly B&H Consulting Services), we are a team dedicated to providing exceptional support for our clients' regulatory needs. We offer a comprehensive suite of services, from crafting winning regulatory strategies to managing electronic submissions and expertly coaching clients for successful FDA meetings. Our diverse client base includes leading pharmaceutical corporations, alongside innovative biotech startups. The Opportunity: Join our dynamic team as a Regulatory Scientist and make a real impact in shaping the future of life-changing therapies. This hybrid role offers the flexibility of in-office and remote work, allowing you to thrive in a collaborative environment while maintaining a healthy work-life balance. What You'll Do:
- Regulatory Strategy: Partner with US and international clients to design and implement regulatory and CMC strategies for the development of new drugs and/or combination products (drug/drug or drug/device).
- Regulatory Submissions: Craft and review regulatory documents to the highest standards, compiling dossiers for FDA and global submissions (INDs, NDAs, BLAs, ANDAs, DMFs, supplements, IMPDs, etc.).
- Consulting and Client Success: Advise clients on regulatory strategy and submissions based on the latest regulatory agency (e.g. FDA, EU, ICH, etc.) guidelines. Interpret and apply regulations to specific project challenges, including identifying necessary amendments and supplements.
- Project Management: Effectively manage multiple projects, keeping teams and clients informed with clear communication and established timelines.
- Collaboration: Gain valuable mentorship from senior regulatory professionals and collaborate with our document management team to deliver exceptional results.
RequirementsWho You Are:
- Proven Expertise: 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.
- Education: BS/BA in Regulatory Sciences or Life Sciences.
- Values: Embody our core values - People, Innovation, Passion and Excellence.
- Detail-Oriented: Possess a meticulous eye for accuracy and strong organizational skills.
- Team Player: Thrive in a collaborative environment and demonstrate excellent communication skills.
- Preferred, not required:
- RAC certification and/or an MS/Ph.D.
- Experience in a consulting environment.
- Experience with eDRLS submissions
BenefitsWhy VCLS:
- Make a Difference: Contribute to the development of life-saving therapies and accelerate progress in the field.
- Learn and Grow: Work alongside industry veterans and gain invaluable mentorship.
- Hybrid Flexibility: Enjoy the best of both worlds with a work-life balance that empowers you.
- Dynamic Environment: Be part of a passionate team dedicated to client success and innovation.
- Growth Potential: Build a rewarding career in a company that fosters continuous learning and development.
VCLS is committed to fostering a diverse and inclusive workplace. We are a proud equal opportunity employer and value 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.