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Sr. Associate Regulatory Affairs

Pfizer


Location:
Lake Forest H1, IL
Date:
09/22/2017
2017-09-222017-10-21
Job Code:
1614064
Pfizer
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Job Details

Job Title Sr. Associate Regulatory Affairs

JobID 1614064

Location: Lake Forest H1, IL

Description Role Summary:

Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products. May serve as a lead regulatory representative to an assigned product or project team.



Responsibilities

Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations. Plans and organizes registration packages. Prepares registration packages in line with local regulatory requirements and guidelines. With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams. Assists in the preparation of agency meeting packages and strategies for agency meetings. Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.



EDUCATIONAL BACKGROUND:



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

A degree in a science related field will assist in problem solving technical issues as they relate to product registrations.



EXPERIENCE:



Three to five years of experience in Regulatory Affairs, Research, Development or related area.



Able to follow scientific arguments.



Good interpersonal skills.

Good oral and written communications skills.



Developing negotiating skills.



Developing understanding of business needs.



PROBLEM SOLVING:



Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.



Identify registration documentation deficiencies and work with colleagues to accomplish resolution.



Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles.



Define and negotiate regulatory strategy with supervision.



Exercise good judgment within policy and regulations.



ACCOUNTABILITY:



Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.



ANALYTICAL ABILITY:



Follows scientific arguments, identifies regulatory scientific data needs and with

supervision solves regulatory issues.



Presents scientific data effectively orally and in writing in a logical and persuasive manner.



AUTHORITY TO ACT:



Provides daily regulatory support to new product development teams and commercial plant support with guidance.



Participates in preparing regulatory strategies. Reviews major submissions,

regulatory commitments, strategy decisions, meeting strategies with regulatory

authorities and changes to resource allocations with manager prior to

execution.



Acts independently on all routine issues, makes judgment and executes.



Approximately 10% travel



+ Hospira Grade 16, Exempt

+ Eligible for Employee Referral Bonus

+ Last day to apply: October 11, 2017



**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.



**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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