Nestlé Health Science
Senior Regulatory Affairs Specialist - Pharma (Remote)
Nestlé Health Science, Des Plaines, Illinois, us, 60019
Senior Regulatory Affairs Specialist - Pharma (Remote)
Senior Regulatory Affairs Specialist - Pharma (Remote) role at
Nestlé Health Science
Nestlé Health Science believes that nutrition, science, and wellness must merge, not collide. The company embraces the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. The 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. Nestlé Health Science brings its best for better lives. The company challenges its people to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. It embraces the entrepreneurial spirit and collaborates with teams that champion focused and forward thinking. The company is committed to fostering professional growth and celebrating the achievements of its people along the way. 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. 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. 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. Develops, monitors, and reports Regulatory Operations’ metrics and dashboards. Participate in the development and training on Regulatory Operations standards and processes. 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. 3+ years of eCTD publishing. Demonstrated expertise utilizing eDMS applications and publishing systems. Applied knowledge of 21 CFR Part 11 compliance, software/system validation. Proficiency in MS Office and Adobe Acrobat PDF publishing submission documents. Ability to foster information, technology, and digital literacy. 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. 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.
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Senior Regulatory Affairs Specialist - Pharma (Remote) role at
Nestlé Health Science
Nestlé Health Science believes that nutrition, science, and wellness must merge, not collide. The company embraces the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. The 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. Nestlé Health Science brings its best for better lives. The company challenges its people to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. It embraces the entrepreneurial spirit and collaborates with teams that champion focused and forward thinking. The company is committed to fostering professional growth and celebrating the achievements of its people along the way. 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. 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. 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. Develops, monitors, and reports Regulatory Operations’ metrics and dashboards. Participate in the development and training on Regulatory Operations standards and processes. 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. 3+ years of eCTD publishing. Demonstrated expertise utilizing eDMS applications and publishing systems. Applied knowledge of 21 CFR Part 11 compliance, software/system validation. Proficiency in MS Office and Adobe Acrobat PDF publishing submission documents. Ability to foster information, technology, and digital literacy. 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. 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.
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