Sr. Manager Regulatory Affairs
Round Lake, IL
Req ID 51058BR
Business Title
Sr. Manager, Regulatory Affairs
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
•Establish and lead a US Regulatory Operations Submissions Management group
•Formulate and implement Regulatory Operations strategies to ensure delivery of compliant regulatory submissions and provide expertise to the planning and delivery of US and global submissions.
•Lead, support and collaborate upon regional and global regulatory operations development activities.
•Lead US Regulatory Operations submissions preparation and publishing activities. (May lead or support collaborative efforts for global submissions)
•Lead and provide guidance and advice to RA and R&D organization and / or global project teams on EU paper and electronic submission requirements and processes.
•Manage and lead the people, processes and technology required to facilitate the production and management of the regulatory submissions to include resource management, team composition and communication while maintaining positive relationships.
•Manage regulatory submissions, submission strategies, acting as a liaison with other parts of Baxter to lead processes to drive for global consistency.
•Manage/represent submissions management on eCTD readiness and impact to current processes while mitigating risk to current submissions during implementation.
•Maintain Regulatory Records both electronic and paper
•Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
•Plan and manage complex projects and prioritize workload
•Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
•Maintain appropriate communication within the RA function, marketing, and other functions primarily at the project team level
•Assess impact of new regulations and provide feedback.
•Set team, group, or service objectives to assure they align with the Regulatory strategy
Job Requirements
•Expert Regulatory knowledge
•Scientific Knowledge
•Ability to oversee multiple projects in a matrix team environment
•Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
•Excellent oral and written communication and presentation skills
•Ability to accomplish results through others
•Ability to lead, coach, and motivate others
•Bachelor's degree or country equivalent in related scientific discipline with a minimum of 7 years experience in RA, including managing people or projects.
•Higher degree/PhD will be an advantage.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
