Randstad Regulatory in Cambridge, Massachusetts
salary:$118.37 - $139.26 per hour
date posted:Tuesday, October 10, 2017
Regulatory Labeling Strategy Lead (Program Manager- Quality/Clinical/Regulatory Affairs- Sr.?)
Provides regulatory expertise and guidance to cross-functional labeling teams for the development review and approval of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP) across various therapeutic areas. Independently facilitates the development and review of CCDSs and US and EU labeling via labeling teams and executive committees. Prepares submission-ready labeling components for US and EU Health Authority submissions. Ensures that there is Labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans. Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging. May contribute to other labeling-related projects as needed.
Education & Qualifications
Bachelor's degree in a scientific discipline or closely related field is required.
Minimum of 8-10 years of regulatory experience in the pharmaceutical/biotechnology industry.
Clinical experience considered.Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling.
Expertise in developing CCDSs.Knowledge of global guidances relevant to labeling, drug development, and commercialization of prescription medicines.
Expertise in EU and US labeling requirements/ guidance and familiarity with US legacy and PLR-formatted labeling. Ability to communicate and resolve issues during labeling reviews and discussions.
Understanding of SPL format and requirements for legacy and PLR labels
Understanding of Electronic Document Management Systems to a sufficient level to support version control and archival of labeling documentation.
Proven ability to independently direct the activities of cross-functional teams.
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
Excellent analytical, technical and problem-solving skills.
A self-starter who motivates, has tact, diplomacy, leadership skills and a flexible and positive approach.
Knowledge of global guidances relevant to labeling, drug development, and commercialization of prescription medicines.
Ability to manage complex projects and timelines in a matrix team environment.
Strong attention to detail and accuracy is a must.
Ability to effectively present information to senior management and to cross-functional teams