Associate Director/Director Regulatory Labeling Full-Time Consultant
My client is a well-established biotech company focused on treating rare/orphan diseases. They were recently ranked as one of the top ten most innovative biotech companies and they are bringing new treatments to market that will make a big impact on small patient populations. Their regulatory affairs team is expanding to accommodate their growling clinical pipeline and they are seeking an Associate Director/Director of Regulatory Labeling Consultant to lead the development, review, and management of US, EU, and International labeling for commercial products. The ideal candidate is someone who is organized, responsible, and collaborative. You should have a high degree of passion for your role within the team and for your contribution to the company. You should be someone who takes your career very seriously, but not yourself!
Responsibilities:
- Provide input on labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CCDS, and assist with the preparation of high quality documents to support the creation of the CCDS and/or changes to the local labeling for assigned projects or marketed products
- Represent REG GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) and work in close collaboration with the Global Regulatory Lead (GRL) and relevant line function expert(s) on creation/maintenance of core labeling documents
- Participate on Product Core Teams and present strategic global labeling issues to Regulatory Management on an ad-hoc/issue-driven basis for assigned projects/products
- Provide input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices
Knowledge and Skills:
- Minimum BS required. Advanced degree preferred
- Minimum 8-10 years’ industry experience with 4-6 years spent in Regulatory Affairs
- Must have experience working with CCDS
- Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
- US and/or EU Labeling experience minimally required and core labeling experience highly desired
- Experience with global labeling processes and management application of Company Core Data Sheets
- Experience in review process, standards, and industry best practice pertaining to labeling
Number of hours worked per week: 30-40 hours
Length of Assignment: 6 months – 1 year; potential to be extended
Position Location: Remote