Regulatory Affairs Associate

Aspire to discover what’s next.

A global specialty pharmaceutical and medication delivery company, Hospira is Advancing Wellness™ by discovering, developing, manufacturing, and marketing high-quality hospital products and technology solutions. We’re among the leaders in our field, backed by decades of experience. We use unique methods to create dramatic results and we empower each employee to explore new ways of improving the safety and effectiveness of patient care – with integrity, speed, and a sense of personal accountability to patients around the world.

To remain at the forefront, we recruit highly qualified individuals who can translate ideas into solutions. We offer internal and external training opportunities to sharpen your skills and assist you in reaching and exceeding all of your career goals.

Regulatory Affairs Associate
In this role, you will assist in the definition of global regulatory requirements and review of data submitted by project team members. You will also assemble and prepare regulatory submissions and other regulatory documents to regulatory agencies.

MAJOR DUTIES AND RESPONSIBILITIES:
With oversight, collaborate with other functional areas to obtain documentation for regulatory purposes, seek expert advice and technical support as required, and ensure accuracy and completeness of all information
Assemble, prepare and submit original registrations, amendments, supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements and guidelines
Prepare responses to action letters and other agency requests
Assist manager in preparation of regulatory strategies and identification of regulatory requirements for submissions to insure the efficient approval and registration of products
Evaluate manufacturing, labeling and promotional material changes for regulatory impact with guidance
REQUIREMENTS
To be successful in this position, you must possess:

Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject is required
Two to three years experience in quality assurance/compliance, regulatory affairs or research and development or related area preferred
Scientific background via formal education and/or previous work experience
Good communication and interpersonal skills

Our people make Hospira an organization of stature, and we’re proud of our accomplishments. We deliver on our commitment to our communities through charitable partnerships, thoughtful giving, product donations, and global relief. We foster a culture of respect, we value integrity above all, and we empower employees to own ideas and be accountable for actions. And we reward performance with diverse avenues for growth, superior education and training, and the types of benefits you’d expect from a market leader.

To what do you aspire?

Bring your aspirations to Hospira. We’ll help you bring them to life.

Apply online at:

https://sjobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?jobId=66848&type=search&JobReqLang=1&recordstart=1&JobSiteId=5100&JobSiteInfo=66848_5100&GQId=0&partnerid=16015&siteid=5100&codes=CRB

Req #: 2120BR

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