Product Life Group, an International Consultant Group, is seeking a US Senior Labeling Scientist to play a pivotal role in shaping the strategic direction of product labeling, working closely with cross-functional teams to ensure that labeling aligns with both regulatory requirements and business goals. In collaboration with the Regulatory Advertising and Promotion (A&P) representative, this role is instrumental in the development and optimization of key regulatory documents such as the TPVP, TCLP, and CCDS. By providing strategic input, the Senior Labeling Scientist ensures that local labeling not only meets FDA guidelines but also supports competitive positioning, market access, and effective product promotion in the US market. This is a full remote, six-month contracting role.
Responsibilities
US Regulatory expert regarding requirements for US regulation of drug labeling,
Ensure all marketed product labeling adheres to regulatory requirements,
Engages in TPVP, TCLP, and CCDS discussions to support development of competitive US labeling,
Leads development and maintenance of US product labeling consistent with the CCDS and FDA regulations/guidelines
Leads Labeling Review Committee meetings to gain labeling alignment among cross-functional subject matter experts,
Providing competitive labeling landscape for reference in labeling development,
Participate in process improvements to enhance efficiency of labeling development and maintenance,
Communicate FDA requirements and trends to others
departments involved in the preparation or review of product labeling,
Ensures product labeling is managed in accordance with applicable procedures utilizing the required document management systems,
Ensures labeling documents in FDA submissions are complete, accurate, and compliant with FDA submission requirements,
Provide support to fellow Labeling Scientists responsible for establishment registrations, drug listing, FDA submission document preparation, and artwork reviews.
Education
B.S. in a scientific discipline or an equivalent combination of education, training, and experience,
Candidates must have a minimum of 7 years experience in Regulatory Affairs and 5 years experience in Regulatory Labeling strategy. In addition, 2 years of Regulatory advertising and promotion review experience preferred,
Expert knowledge of US laws, regulations, and guidances related to pharmaceutical product labeling development,
Strong leadership, communication, interpersonal skills, and an ability to strategically both assess and navigate risk,
Ability to work collaboratively and influence cross-functional teams,
Ability to manage multiple projects and prioritize competing deadlines,
Ability to think strategically and creatively to regulatory challenges.