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Manager Regulatory Affairs Pharmaceutical Lifecycle Management

Pfizer


Location:
Lake Forest, IL 60045
Date:
12/14/2017
2017-12-142018-02-03
Pfizer
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Job Details

Assures that Pfizer CentreOne (PC1) projects are supported in line with the global registration requirements of targeted countries and supports expedient registration of these customer products in a cost effective manner. Manages registrations of existing customer products in compliance with applicable regulations.







This role supports Pfizer CentreOne (PC1) global contract manufacturing business within the Pfizer Essential Health (PEH) business unit. The Manager Regulatory Affairs assures that PC1 projects are supported in line with the global registration requirements of targeted countries and supports expedient registration of these customer products in a cost effective manner. S/he manages registrations of existing customer products (lifecycle management/post approval) in compliance with applicable regulations. This newly created individual contributor role reports to the Associate Director Global Regulatory Affairs.







The Manager will interact with internal colleagues in Regulatory Affairs including Worldwide Regulatory Operations, Pharmaceutical Sciences, Program Management, PC1 business colleagues, and Pfizer Global Supply; and externally with PC1 customers, FDA, and with other international health authorities.







ROLE RESPONSIBILITIES



Develops regulatory strategies for development projects and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities.



Manages the preparation of registration packages and responses to deficiency letters. Negotiates submission data requirements and deliverable dates with PC1 customer and internal technical teams. Author with team members, key pieces of regulatory submissions.



Acts as a point person for PC1 customer for support of regulatory agency interactions (either written or oral) including, as contracted, preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.



Evaluates manufacturing and labeling changes, as applicable, to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.



Maintains awareness of global regulatory legislation and assesses its impact on business and customer product development programs.



Expected travel - 10%.







QUALIFICATIONS:







+ A Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject is required. A Master's Degree or Pharm. D. is preferred. A degree in a scientific field will assist in problem solving technical issues as they relate to product development, manufacture and global registrations.



+ Five to eight years' experience in the pharmaceutical industry or relevant medical device experience as needed for the position; or other FDA-regulated industries (food, chemicals, etc.).



+ Minimum of three years' experience in regulatory affairs, research and development or quality assurance/compliance.



+ Experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency guidance documents and regulations.



+ Able to challenge scientific arguments.



+ Excellent oral and written communication skills.



+ Good interpersonal skills.



+ Good negotiating skills.



+ Good understanding of business needs.



+ Experience with lifecycle management of approved applications preferred







PROBLEM SOLVING:







+ Interprets global regulations to assure regulatory compliance, minimize product cost and reduce development cycles.



+ Negotiates reasonable and attainable regulatory strategies that are innovative and executable in commercial manufacturing facilities.



+ Understands and can challenge scientific arguments, identifies regulatory scientific data needs and solves regulatory issues.



+ Performs complex compliance risk versus business benefit analysis in ambiguous situations and formulates a recommendation for action.



+ Provides efficient, creative answers to complex regulatory problems.







ACCOUNTABILITY:







+ Influences the development of new customer global products and improvements to existing products, which can increase sales and/or reduce compliance risk. A successful regulatory strategy can have a critical impact on eventual revenue by early approval with the best possible label.



+ Approves regulatory data packages and labeling prior to filing and during the approval process. Identification and resolution of issues often impacts time to approval.



+ Suggests and implements system improvements to reduce cycle time and increase efficiency.







ANALYTICAL ABILITY:







+ Analyzes and interprets complex scientific data as well as global regulations.



+ Assesses scientific data provided for registration purposes against regulatory requirements.



+ Identifies gaps in submission strategy and executes plans to mitigate the risk to approval.



+ Summarizes complex technical data.



+ Presents strategies and data to management and regulatory agencies.







AUTHORITY TO ACT:







+ Independently provides daily regulatory support to new customer global product development teams and for maintenance of commercial products.



+ Has the authority to prepare and submit complex regulatory submissions to a PC1 customer.



+ Directs submission related activities by leading the team and motivating the staff to successfully execute regulatory strategies.



+ Makes independent judgments and decisions based on agency regulations and professional experience.



+ Reviews regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution.







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.







Additional Details:



Last Date to Apply for Job: January 10, 2017







Location Information: Preferred location for this role is north suburban Chicago/Lake Forest, IL; this individual could also be located out of the facilities in Kalamazoo, MI; Rocky Mount, NC; or McPherson, KS







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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