Nestlé SA
Senior Regulatory Affairs Specialist - Pharma (Remote)
Nestlé SA, Bridgewater, New Jersey, United States
Overview
Senior Regulatory Affairs Specialist - Pharma (Remote) at Nestlé Health Science focuses on nutrition, science, and wellness. We manage a broad product portfolio and extensive pharmaceutical expertise to prevent, manage, and treat gastrointestinal and metabolic-related diseases. We encourage diverse ideas, entrepreneurial spirit, and professional growth, with opportunities to learn globally and a benefits program supporting wellbeing.
Position Summary The Regulatory Operations Specialist will be a key contributor to the Pharma Regulatory Operations team, accountable for submission operational activities and processes, vendor management, project management, and negotiation. The role requires knowledge of global regulatory dossier events and requirements to drive submission execution.
The Regulatory Operations Specialist must have Regulatory Operations/Publishing experience in global markets across application types (IND, NDA, BLA, MAA, CTA) and demonstrated knowledge of eCTD XML structure and lifecycle management.
Key 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).
Collaborate with Regulatory Leads and cross-functional content authors to develop, track, and maintain submission content plans; ensure timeline alignment and delivery of non-Medical Writing supported documents.
Serve as a Regulatory Operations representative on global submission filings teams, providing input on submission processes, format compliance, timelines, content plans, and deliverables.
Coordinate with Regulatory Operations colleagues and vendors to ensure accurate and quality assembly of submission dossiers and adherence to planned timelines and budget.
Perform submission-readiness editing to meet ICH eCTD specifications and validation criteria, and ensure copyright clearance and submission-readiness of literature references.
Execute regulatory information management tasks including file transfer, storage, tracking, and archiving of regulatory submission documents and correspondence.
Provide Regulatory Intelligence support for proactive monitoring of changes in the regulatory landscape affecting submissions.
Develop, monitor, and report Regulatory Operations metrics and dashboards; analyze data and identify actions for improvement and risk areas.
Contribute to development and training on Regulatory Operations standards (SOPs, templates, guidelines) for preparing submissions and regulatory information management.
Participate in system and process improvements and support department initiatives.
Experience and Education Requirements
Bachelor’s degree or equivalent work experience.
7+ years of Regulatory Operations experience with understanding of pharmaceutical drug development and global submission requirements across US, EU, Canada, Switzerland, UK; ICH, CTD format, and dossier management in biotech/pharmaceutical industry.
3+ years of eCTD publishing experience.
Demonstrated expertise with eDMS applications and publishing systems (e.g., Veeva, Box, SharePoint, DocuBridge), eCTD validation tools, and other publishing/QC tools.
Knowledge of 21 CFR Part 11 compliance and software/system validation.
Proficiency in MS Office (Word, Excel) and Adobe Acrobat for submission documents.
Ability to foster information, technology, and digital literacy; adaptability in ambiguous environments; strong verbal, written, and interpersonal communication skills.
Critical thinking and problem-solving abilities; ability to work independently and in a fast-paced, matrixed environment.
Project management skills to support and prioritize multiple projects; hands-on vendor management experience; experience with system/organization integration activities.
RAPS RAC Certification preferred, but not required.
Compensation:
The approximate pay range for this position is $95,000.00 to $120,000.00. This range is a good faith estimate at the time of posting and final compensation may vary based on knowledge, skills, abilities, and geographic location.
Benefits:
Nestlé offers performance-based incentives and a competitive total rewards package, including a 401k with company match, healthcare coverage, and other benefits. Incentives and benefits may vary depending on the position.
It is our business imperative to remain an inclusive workplace. For veterans and separated service members, we value your skills and invite you to participate fully in our recruitment experience. Nestlé also supports an inclusive environment for individuals with disabilities.
The Nestlé Companies are equal employment opportunity employers. All applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics. If you require accommodations during the recruitment process, please contact accommodations@nestle.com or dial 711 and provide 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
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Position Summary The Regulatory Operations Specialist will be a key contributor to the Pharma Regulatory Operations team, accountable for submission operational activities and processes, vendor management, project management, and negotiation. The role requires knowledge of global regulatory dossier events and requirements to drive submission execution.
The Regulatory Operations Specialist must have Regulatory Operations/Publishing experience in global markets across application types (IND, NDA, BLA, MAA, CTA) and demonstrated knowledge of eCTD XML structure and lifecycle management.
Key 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).
Collaborate with Regulatory Leads and cross-functional content authors to develop, track, and maintain submission content plans; ensure timeline alignment and delivery of non-Medical Writing supported documents.
Serve as a Regulatory Operations representative on global submission filings teams, providing input on submission processes, format compliance, timelines, content plans, and deliverables.
Coordinate with Regulatory Operations colleagues and vendors to ensure accurate and quality assembly of submission dossiers and adherence to planned timelines and budget.
Perform submission-readiness editing to meet ICH eCTD specifications and validation criteria, and ensure copyright clearance and submission-readiness of literature references.
Execute regulatory information management tasks including file transfer, storage, tracking, and archiving of regulatory submission documents and correspondence.
Provide Regulatory Intelligence support for proactive monitoring of changes in the regulatory landscape affecting submissions.
Develop, monitor, and report Regulatory Operations metrics and dashboards; analyze data and identify actions for improvement and risk areas.
Contribute to development and training on Regulatory Operations standards (SOPs, templates, guidelines) for preparing submissions and regulatory information management.
Participate in system and process improvements and support department initiatives.
Experience and Education Requirements
Bachelor’s degree or equivalent work experience.
7+ years of Regulatory Operations experience with understanding of pharmaceutical drug development and global submission requirements across US, EU, Canada, Switzerland, UK; ICH, CTD format, and dossier management in biotech/pharmaceutical industry.
3+ years of eCTD publishing experience.
Demonstrated expertise with eDMS applications and publishing systems (e.g., Veeva, Box, SharePoint, DocuBridge), eCTD validation tools, and other publishing/QC tools.
Knowledge of 21 CFR Part 11 compliance and software/system validation.
Proficiency in MS Office (Word, Excel) and Adobe Acrobat for submission documents.
Ability to foster information, technology, and digital literacy; adaptability in ambiguous environments; strong verbal, written, and interpersonal communication skills.
Critical thinking and problem-solving abilities; ability to work independently and in a fast-paced, matrixed environment.
Project management skills to support and prioritize multiple projects; hands-on vendor management experience; experience with system/organization integration activities.
RAPS RAC Certification preferred, but not required.
Compensation:
The approximate pay range for this position is $95,000.00 to $120,000.00. This range is a good faith estimate at the time of posting and final compensation may vary based on knowledge, skills, abilities, and geographic location.
Benefits:
Nestlé offers performance-based incentives and a competitive total rewards package, including a 401k with company match, healthcare coverage, and other benefits. Incentives and benefits may vary depending on the position.
It is our business imperative to remain an inclusive workplace. For veterans and separated service members, we value your skills and invite you to participate fully in our recruitment experience. Nestlé also supports an inclusive environment for individuals with disabilities.
The Nestlé Companies are equal employment opportunity employers. All applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics. If you require accommodations during the recruitment process, please contact accommodations@nestle.com or dial 711 and provide 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
#J-18808-Ljbffr