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Manager, Regulatory Affairs Combination Products

Pfizer


Location:
Lake Forest H2, IL
Date:
09/19/2017
2017-09-192017-10-18
Job Code:
1052280
Pfizer
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Job Details

Job Title Manager, Regulatory Affairs Combination Products

JobID 1052280

Location: Lake Forest H2, IL

Description A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer 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. Pfizer, 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.

We have an exciting opening for a Manager, Regulatory Affairs supporting our robust Combination Products portfolio in Lake Forest, Illinois. Join us and propel your career in a global setting.

In a key and highly visible role, this individual will act as the regulatory core team member for, and provide regulatory guidance to combination product project teams in a fast paced, highly visible, complex, and at times ambiguous and changeable environment.

• Responsible for the creation of all submission documentation for a project with a large portfolio of products. This includes correspondence, meeting requests and dossier content, including labeling

• Set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation. Must work with all functional areas to obtain needed information on time

• Anticipate the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed.

• Review scientific information to ensure the data is complete, sound, logical, and supports the program goals. Must be able to work with authors to ensure supporting information is clearly and logically written, in order to ensure it is submission ready

• Exquisite attention to detail is required to ensure alignment both within and between dossiers for large portfolio projects, both the incumbent's and those of colleagues

• Able to handle multiple projects of various complexities (very simple to very complex) simultaneously and meet the project goals

• May provide guidance to others on the creation of labeling or dossier contents. May approve labeling.

• Interact and effectively negotiate with regulatory authorities

• Maintain awareness of applicable regulations and guidances and informs project teams of new information, along with its possible impact to the project, as appropriate.

Interprets regulations and ensures regulatory compliance

• Exercises good judgment within company policy and health authority regulations.

• Bachelor's degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject is required. Masters is preferred; Ph.D is highly preferred

• Minimum 5 years of 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

• Excellent written and interpersonal communication skills. Must be able to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner

• 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 lifecycle 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/MENTAL REQUIREMENTS

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. This position requires an evaluation of the candidate's writing skills.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel 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.



Legacy Hospira grade 18



**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.

A career at Pfizer offers opportunity, ownership and impact.



All over the world, Pfizer 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. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



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


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