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Stryker
Tempe, AZ, United States
Stryker Senior Regulatory Affairs Specialist (Remote) Tempe , Arizona Apply Now Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new th
Job Source: StrykerTessenderlo Kerley, Inc.
Phoenix, AZ, United States
Job Description Role Description: Tessenderlo Kerley, Inc. is a manufacturing company with sales in the United States, Canada and over 50 other countries. As the crop protection division of Tessenderlo Kerley, Inc., NovaSource delivers a portfolio of proven and effective crop protection products to niche agricultural markets around the world. The
Job Source: Tessenderlo Kerley, Inc.Tessenderlo Kerley, Inc.
Phoenix
Job Description Job Description Company Description Tessenderlo Kerley, Inc. is a company of diverse businesses unified by shared values. We serve the agricultural, mining, industrial, and water reclamation markets with a broad range of products and technologies. Tessenderlo Kerley’s team members are passionate and committed to meeting our custom
Job Source: Tessenderlo Kerley, Inc.Tessenderlo Kerley, Inc.
phoenix, az
Tessenderlo Kerley, Inc.is a company of diverse businesses unified by shared values. We serve the agricultural, mining, industrial, and water reclamation markets with a broad range of products and technologies. Tessenderlo Kerley’s team members are passionate and committed to meeting our customers’ needs, and our mission to nurture and enhance life
Job Source: Tessenderlo Kerley, Inc.Tessenderlo Group
Phoenix, AZ, United States
Tessenderlo Kerley, Inc. is a company of diverse businesses unified by shared values. We serve the agricultural, mining, industrial, and water reclamation markets with a broad range of products and technologies. Tessenderlo Kerley’s team members are passionate and committed to meeting our customers’ needs, and our mission to nurture and enhance lif
Job Source: Tessenderlo GroupLiberty
Litchfield Park, AZ, United States
Our purpose is sustaining energy and water for life, and it is demonstrated in everything we do as a business, and as an employee team. At Liberty, we hire passionate people who care about doing the right thing for our customers. We are entrepreneurial, creative, and outcome-focused. Here, your natural talent and achievements will flourish in an in
Job Source: LibertyLiberty Utilities
Litchfield Park, AZ, United States
Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) Liberty Utilities Senior Manager, Rates and Regulatory Affairs in Litchfield Park , Arizona Senior Manager, Rates and Regulatory Affairs
Job Source: Liberty UtilitiesConfidential
Phoenix, AZ, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
Job Source: ConfidentialPhoenix, AZ, United States
Job Summary The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next-generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs. The successful candidate should possess a scientific background and will have an understanding of the unique aspects of cell therapy. The ability to deal with ambiguity and think outside the box are critical for this position.
*While this position can be worked remotely, qualified candidates must reside in the U.S. and be permanently authorized to work in the U.S. Responsibilities Work under the director of the RA Director to craft the health authority engagement strategy and interaction plan, drive the formulation of the meeting package, lead the team through meeting rehearsals (if needed) and may moderate the meeting itself.
Prepare, review, compile, and archive regulatory submissions and correspondence. Submission types can vary, may include: Investigational New Drug (IND) applications, Biological License Applications (BLA), Regenerative Medicine for Advanced Therapy (RMAT) Applications, Investigational Device Exemption (IDE), 510(k), and other submissions as necessary.
Work with RA partners at stakeholder organizations to further refine the overall RA strategy.
Ensure project teams, deliverables and business objectives are aligned with RA strategy.
Provide strategic and technical input for regulatory decisions.
Respond to regulatory agency questions within defined timeline.
Monitor emerging regulation changes which have the potential to impact these products and identify impact or solution.
Job Requirements
Bachelor's Degree required with 8+ years of experience in a regulatory function.
2+ years of experience in Cell Therapy.
Demonstrated experience in regulatory filings and support for CGT/ATMP products.
Ability to work strategically within a business critical and high-profile development program.
Experience in preparing regulatory submissions, such as INDs and BLA/NDA.
Proven effective collaboration with regulatory agencies.
A solid knowledge of regulatory affairs, including proven track record of regulatory drug development and experience with major health authority interactions.
Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline).
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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Senior Manager, Regulatory Affairs - Cell Therapies (Remote-based) jobs in Phoenix, AZ, United States
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