Sr. Manager, Regulatory Affairs – CCDS/Drug Labeling
Drive regulatory strategy regarding the company core data sheet and US drug product label(s) and labeling to sustainably support the approval and ongoing compliance throughout the life cycle of US drug products.
In collaboration with cross functional teams, will be responsible for driving CCDS and US labeling initiatives into strategic business and project objectives.
· Develop and obtain approval for revisions to the company core position on safety and efficacy for the compound (CCDS/CCSI)
· Develop and execute US regulatory labeling strategies and plans for complex projects including ongoing compliance for products already on market. Understand and incorporate key labeling requirements and best practices into US labeling strategies.
· Formulate and drive global initiatives as they apply to US labeling well as global labeling traceability requirements within project and product teams.
· Represent or lead the RA labeling function on assigned cross-functional project teams and projects. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team.
· Monitor applicable US regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects.
· Effectively assess impact of emerging US labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
· Effectively perform gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications.
· Establish appropriate cross-functional partnerships within RA and other functions to drive key US labeling strategies and initiatives.
· Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
· May provide direct supervision of individuals
· Sound basis of global regulatory knowledge; expert knowledge of US labeling requirements is required.
· Ability to manage complex projects and timelines in a matrix team environment. Strong project management and organizational skills.
· Strong oral and written communication and presentation skills
· Demonstrated interpersonal skills including strong negotiation and facilitation skills
· Ability to independently identify compliance risks and escalate when necessary
· Ability to lead and coach others
Education and/or Related Experience
· Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5-8 years regulatory experience in RA or related field, including managing people or projects. At least 4 years direct experience with CCDS and/or US drug labeling. Promotional labeling experience will be an advantage.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.