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Regulatory Operations Specialist - Pharma (Remote)

Company: Nestle
Location: Cortlandt Manor
Posted on: June 20, 2022

Job Description:

As a leader in the science of nutrition, Nestl Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life, Nature's Bounty, Vital Proteins, Nuun, Persona Nutrition, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.We have more than 11,000 employees around the world, and products available in over 140 countries._This position is not eligible for Visa Sponsorship._**Requisition ID**169807**Position Summary**Position Summary:The Regulatory Operations Specialist will be a key contributor to the Aimmune Regulatory Operations team with accountability for submission operational activities and processes, vendor management, project management and negotiation skills; and knowledge of global regulatory dossier events and requirements to drive the execution of submissions. The Specialist must have Regulatory Operations/Publishing experience working in global markets, across various application types (IND, NDA, BLA, MAA, CTA), and demonstrated knowledge of eCTD XML structure and lifecycle management.Specific Responsibilities: Oversee end-to-end dossier execution activities including submission planning and execution of all submissions throughout a product's lifecycle (eg., early/late development, post-marketing, etc.) Works directly collaboratively with Regulatory Leads and cross-functional content authors to develop, track, and maintain submission content plans. Works directly with Reg Ops colleagues and vendors, to ensure an accurate and quality assembly of submission dossiers, planned submission timelines are met and managed to budget. Performs submission-readiness document editing to meet ICH eCTD specifications and validation criteria, and Aimmune's Submission-Ready Standards for document development and publishing. Also, ensures copyright clearance and submission-readiness of literature references used to support document development Develops, monitors, and reports Regulatory Operations' metrics and dashboards. Analyzes metrics and recommends appropriate action (improvement/concerns, trend identification). Participates and is a key contributor in systems/submission processes, operational and department improvement activities.Requirements and Skills: Bachelor's degree, or equivalent work experience. 5+ years of Regulatory Operations experience and understanding of the pharmaceutical drug development and global Regulatory submissions requirements in all regions (US, EU, Canada, Switzerland, UK), ICH, CTD format and dossier management in a biotech/pharmaceutical industry. 3+ years of eCTD publishing. Demonstrated expertise utilizing eDMS applications and publishing systems (eg., Veeva, Box, SharePoint, DocuBridge), eCTD Validation tools (Lorenz eValidator, EURS Validator) and other publishing and QC tools (PDF Tools, TRS Toolbox). Proficiency in MS Office: MS Word for document submission-readiness, MS Excel metrics, and Adobe Acrobat PDF publishing submission documents. Applied knowledgeable of 21 CFR Part 11 compliance, software/system validation. Ability to foster information, technology, and digital literacy. Possess critical thinking and problem-solving skills. Excellent verbal, written, and interpersonal communication skills. Ability to work independently and collaboratively, in a fast-paced, matrixed, team environment. Project management skills including the ability to support and prioritize multiple projects. Hands-on vendor management experience. Prior experience with system/organization integration activities. RAPS RAC Certification preferred, but not required.It is our business imperative to remain a very inclusive workplace.To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestl. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestl seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestl home.The Nestl Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at or please dial 711 and provide this number to the operator: 1-._This position is not eligible for Visa Sponsorship._

Keywords: Nestle, Yonkers , Regulatory Operations Specialist - Pharma (Remote), Other , Cortlandt Manor, New York

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