1+ months

Manager, Regulatory Affairs

Lake Forest, IL 60045
Apply Now
Apply on the Company Site
**Role Summary and Responsibilities**

Act as the regulatory core team member for, and provides regulatory guidance to combination product project teams in a fast paced, highly visible, complex, and at times ambiguous and changeable environment.


+ Bachelor's degree is required, PhD preferred.

+ 5-8 years experience in either pharmaceutical or device regulatory affairs, preferably both. Be able to quickly learn the other discipline if inexperienced. Must quickly become effective in both disciplines. Must understand the intent of the regulations to wisely navigate the discrepancies that exist in the application of each set of regulations to combination products, in order to ensure the decisions work well throughout the life-cycle of the products and to set appropriate precedent for future products and projects.

+ Previous experience with combination product regulatory strategy and/or execution is beneficial.

**Physical or Mental Requirements for this position**

Must be able to work in an office environment and at a computer or on the phone throughout the day.

The field of combination products is relatively new and in flux, both in the US and ex-US. The successful individual will embrace the ambiguity in how to meet the intent of both the device and pharmaceutical regulations simultaneously, the continual change in expectations, and the ability to possibly influence company precedent. The successful candidate will have very strong interpersonal skills. This position requires an evaluation of the candidate's writing skills.


+ Eligible for Employee Referral Bonus: Yes


**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer 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. Pfizer 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. Pfizer is an E-Verify employer.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs
Posted: 2019-12-09 Expires: 2020-04-16

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manager, Regulatory Affairs

Lake Forest, IL 60045

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast