Regulatory Affairs Consultant / Senior Consultant - Labeling (Remote)
Company: PAREXEL
Location: Salem
Posted on: August 5, 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!
Parexel s 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 activities
Qualifications
Education and Experience
- Bachelor s 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 considered
- Good working knowledge of key labeling regulations/guidance and
past experience in label development (CCDS, USPI, packaging)
- The ability to research and create comparator labeling
documents
- Strong understanding and past experience creating annual
reports
- The ability to collaborate with Tech Ops for artwork
implementation
- Proficiency 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 experience Knowledge and Skills
- Strong attention to detail
- Solid understanding and interpretation of US labeling
regulatory requirements preferred
- Solid 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 practice
- Solid 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
applications
- Understanding of label development and submission processes
preferred.
- Ability to recognize and escalate issues
- Strong written and oral communication and organizational
skills
- Ability 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 teams This is
a home-based role; however, in the % 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 Disclaimer
Parexel 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.
Keywords: PAREXEL, Salem , Regulatory Affairs Consultant / Senior Consultant - Labeling (Remote), Professions , Salem, Massachusetts
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