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Manager, RA Pharma Safety & Efficacy

Boehringer Ingelheim · Johns Creek, GA · 1 mo ago
ManagementFull-time

About the role

The Manager, RA Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global development projects and provide regulatory strategy for assigned projects that leads to a reliable and efficient timeline for product approval.

Responsibilities

  • Responsible for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable
  • Works in project teams as an RA sub team member in accordance with the project governance model to drive Target Product Profile objectives
  • Provides consistent regulatory advice to project teams regarding the pathways and approaches to regulatory approvals with details pertaining to time to market, costs, and robustness/marketability of each approval
  • Represents company at external functions, such as trade association meetings, to support BI interests
  • Participates in due diligence processes by providing input into the regulatory assessment
  • Participates in the evaluation of the product dossiers for regulatory compliance and suitability for registration
  • Represents RA for infrastructural processes and projects
  • Supports specific infrastructural projects as assigned

Requirements

  • Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry OR Masters in relevant scientific discipline with minimum seven (7) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry
  • Excellent command of English language, both written and spoken
  • Regulatory Affairs or equivalent pharma industry experience is required
  • Intrapreneurial spirit while being rigorous and disciplined with compliance requirements
  • Able to collaborate in a global organization and manage a full workload across multiple projects
  • Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships
  • Able to meet stringent time and quality demands
  • Strong team player who is collaborative with the mission of BI, but able to drive change
  • Able to handle high workloads and understanding of cultural differences
  • Well-developed organizational capabilities
  • Self-motivated

Qualifications

Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry OR Masters in relevant scientific discipline with minimum seven (7) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry

Skills

  • Excellent command of English language, both written and spoken
  • Regulatory Affairs or equivalent pharma industry experience is required
  • Intrapreneurial spirit while being rigorous and disciplined with compliance requirements
  • Able to collaborate in a global organization and manage a full workload across multiple projects
  • Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships
  • Able to meet stringent time and quality demands
  • Strong team player who is collaborative with the mission of BI, but able to drive change
  • Able to handle high workloads and understanding of cultural differences
  • Well-developed organizational capabilities

Benefits

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow.

Pay

Competitive compensation and benefits package

Schedule

Full-time

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