Nestlé Health Science
Senior Regulatory Affairs Specialist - Pharma (Remote)
Nestlé Health Science, Bridgewater, Massachusetts, us, 02324
Senior Regulatory Affairs Specialist - Pharma (Remote)
Nestlé Health Science believes that nutrition, science, and wellness must merge, not collide. 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 also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases. We bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. 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. 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 ensures copyright clearance and submission-readiness of literature references used to support document development. 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 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. 3+ years of eCTD publishing. Demonstrated expertise utilizing eDMS applications and publishing systems, eCTD Validation tools and other publishing and QC tools. 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. The approximate pay range for this position is $95,000.00 to $120,000.00. Nestlé 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. Nestlé is an equal employment opportunity employer. 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.
#J-18808-Ljbffr
Nestlé Health Science believes that nutrition, science, and wellness must merge, not collide. 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 also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases. We bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. 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. 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 ensures copyright clearance and submission-readiness of literature references used to support document development. 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 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. 3+ years of eCTD publishing. Demonstrated expertise utilizing eDMS applications and publishing systems, eCTD Validation tools and other publishing and QC tools. 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. The approximate pay range for this position is $95,000.00 to $120,000.00. Nestlé 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. Nestlé is an equal employment opportunity employer. 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.
#J-18808-Ljbffr