Nestle
Senior Regulatory Affairs Specialist - Pharma (Remote)
Nestle, Bridgewater, New Jersey, United States
At Nestle Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life, Nature's Bounty, Vital Proteins, Orgain, Nuun, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more.
We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.
Position Summary:
The Regulatory Operations Specialist will be a key contributor to the Pharma 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. Key Responsibilities:
Oversee end-to-end dossier execution activities including submission planning and execution of all submissions throughout a product's lifecycle. Works directly collaboratively with Regulatory Leads and cross-functional content authors to develop, track, and maintain submission content plans; and on timeline alignment and delivery of non-Medical Writing supported documents. Serves as a Regulatory Operations representative on global submission filings teams, working cross-functionally to provide input and guidance related to submission processes, compliance to required submission formats, timelines, submission content plans and deliverables. Works directly with Regulatory Operations colleagues and vendors, to ensure an accurate and quality assembly of submission dossiers and 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. Executes regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondence. Provides Regulatory Intelligence support for proactive global monitoring and surveillance of changes in the regulatory landscape focused on regulatory submissions requirements, potential regulatory operations business impact, emerging technologies, pending regulations and guidance documents. Develops, monitors, and reports Regulatory Operations' metrics and dashboards. Analyzes metrics and recommends appropriate action. Participate in the development and training on Regulatory Operations standards and processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management. Participates and is a key contributor in systems/submission processes, operational and department improvement activities. Experience and Education Requirements:
Bachelor's degree, or equivalent work experience. 7+ 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). Applied knowledgeable of 21 CFR Part 11 compliance, software/system validation. Proficiency in MS Office: MS Word for document submission-readiness, MS Excel metrics, and Adobe Acrobat PDF publishing submission documents. Ability to foster information, technology, and digital literacy. Demonstrated agility and adaptability during times of ambiguity. Excellent verbal, written, and interpersonal communication skills. Possess critical thinking and problem-solving 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. Nestle offers performance-based incentives and a competitive total rewards package, which includes a 401k with company match, healthcare coverage and a broad range of other benefits. The Nestle Companies are equal employment opportunity employers. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status or any other characteristic protected by applicable law.
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The Regulatory Operations Specialist will be a key contributor to the Pharma 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. Key Responsibilities:
Oversee end-to-end dossier execution activities including submission planning and execution of all submissions throughout a product's lifecycle. Works directly collaboratively with Regulatory Leads and cross-functional content authors to develop, track, and maintain submission content plans; and on timeline alignment and delivery of non-Medical Writing supported documents. Serves as a Regulatory Operations representative on global submission filings teams, working cross-functionally to provide input and guidance related to submission processes, compliance to required submission formats, timelines, submission content plans and deliverables. Works directly with Regulatory Operations colleagues and vendors, to ensure an accurate and quality assembly of submission dossiers and 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. Executes regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondence. Provides Regulatory Intelligence support for proactive global monitoring and surveillance of changes in the regulatory landscape focused on regulatory submissions requirements, potential regulatory operations business impact, emerging technologies, pending regulations and guidance documents. Develops, monitors, and reports Regulatory Operations' metrics and dashboards. Analyzes metrics and recommends appropriate action. Participate in the development and training on Regulatory Operations standards and processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management. Participates and is a key contributor in systems/submission processes, operational and department improvement activities. Experience and Education Requirements:
Bachelor's degree, or equivalent work experience. 7+ 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). Applied knowledgeable of 21 CFR Part 11 compliance, software/system validation. Proficiency in MS Office: MS Word for document submission-readiness, MS Excel metrics, and Adobe Acrobat PDF publishing submission documents. Ability to foster information, technology, and digital literacy. Demonstrated agility and adaptability during times of ambiguity. Excellent verbal, written, and interpersonal communication skills. Possess critical thinking and problem-solving 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. Nestle offers performance-based incentives and a competitive total rewards package, which includes a 401k with company match, healthcare coverage and a broad range of other benefits. The Nestle Companies are equal employment opportunity employers. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status or any other characteristic protected by applicable law.
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