Regulatory Affairs Consultant / Senior Consultant - Labeling (Remote)
Company: Parexel
Location: Salem
Posted on: August 6, 2022
Job Description:
INCREDIBLE HOME-BASED OPPORTUNITY DEDICATED TO ONE CLIENT!
If you passionate about labeling, have a passion for Regulatory
Affairs, and are looking for an opportunity to work with an amazing
team, then Parexel's Consulting has the perfect opportunity for
you!
Parexels Consulting Team is expanding, and we are seeking a
Senior/Consultant, Regulatory Labeling to partner with our global
client on US related labeling activities!
As a Senior/Consultant, Regulatory Labeling, you will partner with
Label Strategist to:
Conduct international labeling
operations activities to support global new product and
supplemental applications to product registration, and post
approval launches for impacted international markets.Collaborate
with Technical Operations team members to ensure commercial
distribution, Regulatory Technology for labeling submissions, PV
for safety reporting, and other functional groups. Provide labeling
to Advertising and Promotion for marketing pieces, and with
Commercial for website postings if needed.Work with Regulatory
Operations, Regulatory Affairs, Tech Ops, etc. for labeling
distribution, tracking and quality control.Utilize
regulatory/product knowledge to provide operational support to
ensure that labeling materials meet regulatory and company
requirements and timelines.You will also:
Be responsible for executing and
effective quality control reviews and tracking (primarily)
internally used labeling documents (Core Data Sheet, Core Patient
Information Leaflet, Core Instructions for Use) and outward facing
local/regional labeling (USPI, Med Guide, SmPC, PIL, Canadian
Product Monograph, Instructions for Use) as well as container and
carton labels to meet regional regulatory requirements and ensure
consistency between labeling, labels and supportive documents.Act
as operational expert for the Global Labeling tracking in RIMs, SPL
generation, ensure development and maintenance of templates,
collaboration features and system upgrades.Contribute to the
continuous improvement of the end-to-end labeling process including
excellent proofreading/editing skills and compiling supportive
documentation.Support labeling inspection / audit readiness
activitiesQualificationsEducation and Experience
Bachelors Degree plus at least 4+
years of experience in drug development especially in labeling,
product package coordination, clinical supplies/packaging, supply
chain regulatory affairs, or quality. Exceptional candidates with
3+ years of labeling related experience may also be consideredGood
working knowledge of key labeling regulations/guidance and past
experience in label development (CCDS, USPI, packaging)The ability
to research and create comparator labeling documentsStrong
understanding and past experience creating annual reportsThe
ability to collaborate with Tech Ops for artwork
implementationProficiency in SPL (all aspects, types and
troubleshooting) and the ability to manage the review and approval
of labeling in a document management system. Electronic document
management systems use and / or electronic submission
experienceKnowledge and Skills
Strong attention to detailSolid
understanding and interpretation of US labeling regulatory
requirements preferredSolid understanding of requirements for
tracking of labeling updates Solid understanding of the
pharmaceutical industry drug development process and willingness to
learn global labeling regulatory requirements and industry
practiceSolid aptitude for use of IT systems; Regulatory
Information Management System (RIMS), electronic document
management system (EDMS), Proficiency in MS Office suite; Willing
to learn additional applicationsUnderstanding of label development
and submission processes preferred.Ability to recognize and
escalate issuesStrong written and oral communication and
organizational skillsAbility to generate and initiate problem
solving innovative solutions The ideal candidate should be action
oriented, customer focused, ability to manage workloads and set
priorities. In addition, he/she should be capable of dealing with
ambiguity, be creative, be comfortable working with multifunctional
teamsThis is a home-based role; however, in the future @ 15%
domestic / international travel may be required to client offices
coupled with flexibility to travel to Parexel's offices for
team/client meetings
Employment is contingent on disclosure of your COVID-19 vaccination
status and, if relevant, proof of vaccination.
EEO DisclaimerParexel is an equal opportunity employer. Qualified
applicants will receive consideration for employment without regard
to legally protected status, which in the US includes race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.#LI-REMOTEby
Jobble
Keywords: Parexel, Salem , Regulatory Affairs Consultant / Senior Consultant - Labeling (Remote), Professions , Salem, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...
