Veterans Jobs - Sr. Associate Regulatory Affairs, Generics in Lake Forest H1, Illinois, United States job in Lake Forest H1
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|City:||Lake Forest H1|
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.
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.
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.
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.
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.
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.
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
Acts independently on all routine issues, makes judgment and executes.
Approximately 10% travel
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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.
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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