About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Hospira, a the company company, is a leading provider of infusion technologies. The company's focused infusion systems portfolio features I.V. solutions, proven, innovative smart pumps, and pain management and safety software technology designed to help meet clinical, safety and workflow goals.
We have an exciting opening in our Global Regulatory Organization for an Associate Director, Regulatory Affairs. In a highly visible and strategic role, the incumbent will lead the oversight for Hospira's US based team that supports global pharmaceutical marketed product portfolio from launch through market withdrawal globally. S/he will develop and implement global regulatory strategies to maintain existing registrations in compliance with applicable global regulations. As a key member of the leadership team, they will provide regulatory consult on Manufacturing Operations initiatives and derive innovative strategies to progress with Global Health Authorities.
• Provide global regulatory impact assessment for changes to currently approved products in line with global regulations
• Define and implement regulatory strategies and priorities in support of changes to approved products
• Advise program/teams on regulatory requirements, coordinates and presents regulatory data needs, and negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met
• Manage the preparation and review of registration packages to ensure effective data presentation and quality
• Propose new/revised policies and recommend standard interpretation of global regulations
• Maintain an awareness of global legislation and assess its impact on the business and product development programs
• Create systems to assure regulatory compliance, and strives to ensure that products remain in compliance
• Manage the processes to achieve regulatory agency input
• Request, manage and facilitate agency meetings
• Ten years experience in the pharmaceutical industry as needed for the position, proprietary and/or biologics product development preferred.
• Minimum of five years experience in regulatory affairs, with a focus on biologic and/or proprietary drug development preferred.
• Experience working directly with regulatory agencies.
• Sound knowledge of applicable portions of global regulatory guidances and regulations.
• Excellent communications skills at all levels - both internally and externally. Strong interpersonal skills. Proven negotiating skills. Strong management skills.
• Experience in contract manufacturing, development or other customer service related experience preferred.
Other Information - Internal
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Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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