Job Description :
Develop and execute global regulatory labeling strategies and plans for complex projects including new products and ongoing global compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies.
Formulate and drive global labeling traceability requirements within project and product teams.
Represent or lead the RA labeling function on assigned cross-functional project teams and projects to develop global device labeling requirements and labeling content. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team.
Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects.
Effectively assess impact of emerging global 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.
Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key global labeling strategies and initiatives.
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
1. Sound basis of global regulatory knowledge. Expert device labeling requirements and implementation will be an advantage.
2. Ability to manage complex projects and timelines in a matrix team environment. Strong project management and organizational skills.
3. Strong oral and written communication and presentation skills
4. Demonstrated interpersonal skills including strong negotiation and facilitation skills
5. Ability to independently identify compliance risks and escalate when necessary
6. Ability to lead and coach others