Senior Regulatory Affairs Specialist - Pharma (Remote)

Nestle; Chicago (IL); Remote; USD 95,000 - 120,000; Full time

Job summary

A leading health and nutrition company in Chicago seeks an experienced Regulatory Operations Specialist to manage submission processes and vendor relationships. The ideal candidate will have over 7 years of experience in Regulatory Operations and will work collaboratively with cross-functional teams. This position offers a competitive salary and a robust benefits package.

Benefits

401k with company match

Healthcare coverage

Performance-based incentives

Qualifications

• Minimum of 7 years of Regulatory Operations experience.
• Understanding of global Regulatory submissions in all regions.
• 3+ years of eCTD publishing experience.

Responsibilities

• Oversee dossier execution activities for submissions.
• Collaborate with Regulatory Leads for submission content.
• Maintain submission content plans and timelines.

Skills

Regulatory Operations experience

eCTD publishing

Project management

Vendor management

MS Office proficiency

Education

Bachelor’s degree or equivalent

Tools

Veeva

Adobe Acrobat

DocuBridge

Job description

Overview

At Nestlé 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 also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.

At Nestlé Health Science, 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. 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.

Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.

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.

The Regulatory Operations 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.

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, etc.)
• 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. Also, 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 (areas for improvement, trend identification, areas of concern).
• 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. #LI-SF1

The approximate pay range for this position is $95,000.00 to $120,000.00. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location.

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. Incentives and/or benefit packages may vary depending on the position. Learn more at About Us | Nestlé Careers (nestlejobs.com) (https://www.nestlejobs.com/nestle-in-the-us).

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 Nestlé. 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. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.

The Nestlé 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. 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 [e-mail] or please dial 711 and provide this number to the operator: 1-800-321-6467.

This position is not eligible for Visa Sponsorship.

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Job Requisition: 373044