Program Manager - Quality/Clinical/Regulatory Affairs- Senior in Cambridge, MA at Apex Life Sciences

Date Posted: 2/12/2018

Job Snapshot

Job Description




This position if for a REMOTE Regulatory Labeling Strategy Lead 

For immediate consideration, email your updated resume and contact information to dsimpson@apexlifesciences.com

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) in various therapeutic areas, including GI, endocrine, metabolism and oncology. 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 and Experience: 
• Bachelor's degree in a scientific discipline or closely related field is required. 
• Minimum of 5-7 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. 
Key Skills: 
• 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.