Regulatory Operations Specialist - Pharma (Remote)
Company: Nestle
Location: Cortlandt Manor
Posted on: June 20, 2022
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Job Description:
As a leader in the science of nutrition, Nestl Health Science
believes in empowering healthier lives for patients and consumers
through a rich product portfolio featuring top brands such as
Garden of Life, Nature's Bounty, Vital Proteins, Nuun, Persona
Nutrition, BOOST, Carnation Breakfast Essentials, Peptamen,
Compleat Organic Blends, and more, as well as through Aimmune
Therapeutics, a biopharmaceutical company developing therapies to
prevent, manage and treat food, GI and metabolic-related
diseases.Our team members are challenged to make a genuine impact
and play an integral role in driving the business forward. We
embrace a dynamic culture that always puts the consumer first, and
where ownership, accountability and agility are celebrated at every
level. To help our people thrive, we offer expansive career growth
potential, the opportunity to work alongside and learn from
talented colleagues with diverse backgrounds and skill sets, and a
range of best-in-class benefits.We have more than 11,000 employees
around the world, and products available in over 140
countries._This position is not eligible for Visa
Sponsorship._**Requisition ID**169807**Position Summary**Position
Summary:The Regulatory Operations Specialist will be a key
contributor to the Aimmune 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 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.Specific 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.
Works directly with Reg Ops colleagues and vendors, to ensure an
accurate and quality assembly of submission dossiers, 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
Develops, monitors, and reports Regulatory Operations' metrics and
dashboards. Analyzes metrics and recommends appropriate action
(improvement/concerns, trend identification). Participates and is a
key contributor in systems/submission processes, operational and
department improvement activities.Requirements and Skills:
Bachelor's degree, or equivalent work experience. 5+ 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). Proficiency in MS Office: MS Word for document
submission-readiness, MS Excel metrics, and Adobe Acrobat PDF
publishing submission documents. Applied knowledgeable of 21 CFR
Part 11 compliance, software/system validation. Ability to foster
information, technology, and digital literacy. Possess critical
thinking and problem-solving skills. Excellent verbal, written, and
interpersonal communication 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.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 Nestl. 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. Nestl
seeks such skilled and qualified individuals to share our mission
where you'll join a cohort of others who have chosen to call Nestl
home.The Nestl Companies are an equal employment opportunity and
affirmative action employer seeking diversity in qualified
applicants for employment. All applicants will receive
consideration for employment without regard to race, ethnicity,
color, gender, gender identity, age, religion, national origin,
ancestry, disability, perceived disability, medical condition,
genetic information, veteran status, sexual orientation, or any
other protected status, as defined 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 or please dial 711 and provide this number to the operator:
1-._This position is not eligible for Visa Sponsorship._
Keywords: Nestle, Yonkers , Regulatory Operations Specialist - Pharma (Remote), Other , Cortlandt Manor, New York
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