Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy

Description

Manager

The Manager, Regulatory Affairs (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. The expectation of the position holder will be to understand pertinent regulations and guidance and ensure the project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to ensure sufficient and efficient communication through activities such as governance review, project team meetings, planning activities and FDA communications.

 

Associate Director

Act as Regulatory Affairs (RA) core or subteam member in projects as well as in program teams. Anticipate changes in pertinent regulations and evaluate impact on projects/existing products. Define sound regulatory strategies for assigned products/projects within the team and ensure regulatory compliance with regards to safety and efficacy. The position will link the safety and efficacy regulatory team with internal stakeholders and external stakeholders (regulatory agencies) to ensure comprehensive synergies between regulatory, research, developmentand business activities in accordance with the strategic plan of the company. 

 

 

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

Manager

• 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.
• Responsible for coordinating technical input for Freedom of Information Summary and product labeling for assigned projects.
• 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.
• Responsible for the successful update of regulatory tools as defined.
• Supports specific infrastructural projects as assigned.

 

Associate Director

• Responsibility 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.
• Responsibility for coordinating technical input for Freedom of Information Summary and product labeling for assigned projects.
• Work in project teams in accordance with the project governance model to drive Research Profile/Target Product Profile and Quality Target Profile.
• Provide 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.
• Serve as RA core team member for project teams.
  • The role of a RA core team member includes steering all regulatory aspects of development and includes leading of subteams.
• Serve as Subject Matter Expert on the current US regulatory environment and potential trends. Recommend and communicate proactive approaches to regulatory issues.
• Facilitate partnerships, both formal and informal, with key regulatory agency review staff.
• Participate in due diligence processes by providing regulatory assessment and expertise.
• Responsib