Associate Director Biogenerics, Global Regulatory Affairs

Aspire to set new standards for excellence.

A global specialty pharmaceutical and medication delivery company, Hospira is Advancing WellnessTM 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.

As a leader and an innovator, we take great care to hire, develop, and keep the right people ? people of integrity who are motivated by challenges, take ownership of their careers, embody our values and embrace entrepreneurial spirit.

Associate Director Biogenerics, Global Regulatory Affairs

In this role, you will advise program/teams on regulatory requirements, coordinate and present regulatory data needs, and negotiate with and influences management, colleagues and partners to ensure regulatory data requirements are met. You will also define and implement regulatory strategies and priorities and propose new/revised policies and recommend standard interpretation of global regulations. You will also manage the preparation and review of registration packages to ensure effective data presentation and quality.

In addition, you will conduct due diligence regulatory assessment and communicate recommendations to senior management, while maintaining an awareness of global legislation and assess its impact on the business and product development programs. You must also create systems to assure regulatory compliance, and strive to ensure that products remain in compliance and manage the processes to achieve regulatory agency input into research and development programs..

To be successful in this position, you must possess:

Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject required, advanced degree preferred.

Ten years experience in the pharmaceutical industry and a minimum of seven years experience in regulatory affairs, with three years in biologic regulatory affairs preferred.

Experience working directly with regulatory agencies.

Sound knowledge of applicable portions of agency guidances and regulations.

Excellent communications skills at all levels - both internally and externally.

Strong interpersonal skills.

Proven negotiating skills.

Strong management skills.

Hospira offers an agile, yet balanced work culture and the types of compensation and benefits you?d expect from an industry leader. We provide the tools and resources you need to reach and exceed your career goals through professional development, education reimbursement, and much more.

To what do you aspire?

Learn more about us and apply online:

https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?jobId=66788&type=search&JobReqLang=1&recordstart=1&JobSiteId=5100&JobSiteInfo=66788_5100&partnerid=16015&siteid=5100

Req #: 2115BR

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