Job Title: Manager, Regulatory Affairs
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Partner with R&D in bringing new products to market.
Develop RA strategies for new Pharmaceutical products, including Global launch plans.
Develop and submit IND/NDA applications to FDA.
Develop RA strategies for new or revised Medical Device products.
Develop and submit 510k to FDA
Represent CareFusion in direct interaction with FDA and other National Regulatory Agencies in delivery of the above.
Manage the work of more junior RA team members to deliver the above
Job Family Summary
Regulatory Affairs Manager (FDA) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
What is expected of you for success in your role
Demonstrates advanced knowledge of healthcare-related regulations
Demonstrates comprehensive knowledge of healthcare-related regulations
Demonstrates an advanced understanding of the regulatory and legislative process
Knows how to effectively interact with outside consultants or lobbyists
Demonstrates in-depth understanding of the healthcare industry, CareFusion products and services and our customers and competitors
Assesses existing and developing regulations and statutes and identifies whether they may have current and/or long term impact upon CareFusion products and services
Utilizes in-depth research capabilities to identify regulations and other relevant information (e.g., guidance documents, standards, etc.)
Assesses trends and changes in regulations and statutes to help determine their strategic impact
Assists in developing strategies on an issue-specific basis that will further CareFusion business initiatives or prevent business disruption
Drafts formal written comments that will be submitted to regulatory bodies
May be involved in reviewing written comments submitted by other businesses
Develops approach, rationale and supporting advocacy position concerning a proposed or existing regulation
Has depth and breadth of experience in own job family; integrates knowledge of business and functional priorities
Applies in-depth skills and broad knowledge of the business to address complex problems and non-standard situations
Acts as a key contributor in a complex environment
May lead teams or projects; shares expertise
Learn more about Chloraprep
Bachelor's degree strongly recommended
Advanced degree preferred
6-8 years of experience
Must be an expert in Pharmaceutical and Medical Device regulations.
Experience working in Pharmaceutical Industry is required.
Must have 510k submissions experience and NDA routes having demonstrated track record of successful gaining market access in United States
Familiarity with EU, CE and MA routes of market access
CareFusion Corporation - 14 months ago