Sr. Associate, Regulatory Affairs

Aspire to achieve the highest quality standards

At Hospira we take our responsibility for work that saves lives seriously. As a provider of innovative medication-management and healthcare work-safety solutions, Hospira is a leader in our market, manufacturing technology, and customer service.

As an entrepreneurial, proactive company, we’re at the forefront — often ahead of mandates — in protecting healthcare workers against injury, reducing medication errors, and improving patient safety. We’re renowned for our breadth of product, the absolute cleanliness of our plant, and the high caliber of our people— goal-oriented individuals who are focused on quality and execution.

Sr. Associate, Regulatory Affairs
In this role you will manage a regulatory operations group which prepares, submits and archives regulatory submissions. Submissions are processed for drug and device applications, are prepared in paper and electronic format, and are submitted to US and ex US regulatory authorities. You will also be responsible for supervising 4-6 support staff. In addition you will be responsible for the implementation and transition of electronic submission processes and tools into the regulatory operations group.
REQUIREMENTS
To be successful in this position, you must possess:

Bachelor’s degree required (Degree in a scientific or information technology discipline preferred)
3+ years of experience in Regulatory Affairs, Compliance, Research & Development or cGMP Operations required
Experience with Documentum, Core Dossier or other electronic publishing systems/tools preferred
Experience with project and people management preferred
Proficiency with desktop computer programs (Word, Excel, etc) required

Hospira offers a balanced work culture as well as competitive compensation and benefits. As a leader in our industry, we offer tremendous opportunities, tools and resources for motivated individuals to advance in their careers.

To what do you aspire?

Learn more about us and apply online:

https://sjobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?jobId=76002&type=search&JobReqLang=1&recordstart=1&JobSiteId=5100&JobSiteInfo=76002_5100&GQId=0&partnerid=16015&siteid=5100&codes=CRB

Req #: 2442BR

As an equal opportunity/affirmative action employer, Hospira embraces diversity of thought and cultural perspective and fosters an environment of empowerment, fairness and respect.