Boehringer Ingelheim
Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy
Boehringer Ingelheim, Duluth, Georgia, United States, 30155
Overview
Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy — Boehringer Ingelheim Join to apply for the
Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy
role at
Boehringer Ingelheim . Describe the regulatory safety & efficacy function in global development projects, provide regulatory strategy, and ensure US requirements are met in development activities. The role involves FDA meetings and submissions, and linking regulatory information to internal and external stakeholders to ensure effective communication through governance reviews, project team meetings, planning activities, and FDA communications. 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 Coordinate technical input for Freedom of Information Summary and product labeling for assigned projects Collaborate in project teams as an RA sub team member to drive Target Product Profile objectives Provide regulatory advice to project teams regarding pathways and approaches to regulatory approvals with details on time to market, costs, and robustness/marketability Represent the company at external functions (e.g., trade association meetings) to support BI interests Participate in due diligence processes by providing regulatory input Evaluate product dossiers for regulatory compliance and suitability for registration Represent RA for infrastructural processes and projects Coordinate successful updates of regulatory tools as defined Support specific infrastructural projects as assigned Responsibilities – Associate Director
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 Coordinate technical input for Freedom of Information Summary and product labeling for assigned projects Work in project teams to drive Research Profile/Target Product Profile and Quality Target Profile Provide regulatory advice to project teams regarding pathways to regulatory approvals with details on time to market, costs, and robustness/marketability Serve as RA core team member for project teams The RA core team role includes steering all regulatory aspects of development and leading subteams Serve as Subject Matter Expert on the current US regulatory environment and potential trends; recommend proactive approaches to regulatory issues Facilitate partnerships with key regulatory agency review staff Participate in due diligence with regulatory assessment and expertise Evaluate product dossiers for regulatory compliance and suitability for registration Proactive representation of RA for infrastructural processes and projects Lead or support infrastructural projects as assigned Represent the company at external functions to drive BI interests Communicate with regulatory authorities and industry associations Proactively seek contact with regulatory authorities and position BI as a trusted partner Maintain a balanced relationship with authorities Requirements Manager – Requirements
Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related Regulatory Affairs or equivalent/pharmaceutical industry experience OR Master’s in relevant scientific discipline with minimum seven (7) years related experience Excellent command of English, written and spoken Regulatory Affairs or equivalent pharma industry experience required Intrapreneurial spirit with rigorous compliance Ability to collaborate in a global organization and manage multiple projects Effective communication, negotiation, and interpersonal skills Ability to meet stringent time and quality demands Strong teamwork and change-driving ability Ability to handle high workloads and understand cultural differences Well-developed organizational capabilities Self-motivated Associate Director – Requirements
Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum five (5) years Regulatory Affairs strategy/execution experience OR Master’s in relevant scientific discipline with minimum ten (10) years experience Excellent command of English, written and spoken At least five (5) years in Regulatory Affairs roles, or equivalent in pharma Minimum two to three (2–3) years interacting with authorities (e.g., in new product development or complex maintenance projects, leadership of RA subteams) Knowledge of legal requirements for veterinary product approval Understanding of industry activity and regulatory trends Knowledge in relevant Regulatory Affairs areas; focus on safety and efficacy Regulatory affairs experience in animal health including prior FDA/CVM/EPA interaction Intrapreneurial spirit with rigorous compliance Proven ability to collaborate in a global organization across multiple projects Effective communication and ability to form productive relationships across disciplines and nationalities Ability to meet stringent time and quality demands; capable of developing systems for rapid outcomes Self-motivated with initiative and persistence Well-developed organizational capabilities Strong team player with BI mission alignment Ability to handle high workloads and understand cultural differences Desired Skills, Experience And Abilities Knowledge in international product registration and/or product development is desired Eligibility Requirements
Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older Our Company
Why Boehringer Ingelheim? With us, you can develop your own path in a company that values diversity and teamwork, and offers opportunities to contribute to patients and customers. We support our employees with programs for health and wellbeing, work-life balance, and career development. Visit our site for more information: https://www.boehringer-ingelheim.com
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Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy — Boehringer Ingelheim Join to apply for the
Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy
role at
Boehringer Ingelheim . Describe the regulatory safety & efficacy function in global development projects, provide regulatory strategy, and ensure US requirements are met in development activities. The role involves FDA meetings and submissions, and linking regulatory information to internal and external stakeholders to ensure effective communication through governance reviews, project team meetings, planning activities, and FDA communications. 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 Coordinate technical input for Freedom of Information Summary and product labeling for assigned projects Collaborate in project teams as an RA sub team member to drive Target Product Profile objectives Provide regulatory advice to project teams regarding pathways and approaches to regulatory approvals with details on time to market, costs, and robustness/marketability Represent the company at external functions (e.g., trade association meetings) to support BI interests Participate in due diligence processes by providing regulatory input Evaluate product dossiers for regulatory compliance and suitability for registration Represent RA for infrastructural processes and projects Coordinate successful updates of regulatory tools as defined Support specific infrastructural projects as assigned Responsibilities – Associate Director
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 Coordinate technical input for Freedom of Information Summary and product labeling for assigned projects Work in project teams to drive Research Profile/Target Product Profile and Quality Target Profile Provide regulatory advice to project teams regarding pathways to regulatory approvals with details on time to market, costs, and robustness/marketability Serve as RA core team member for project teams The RA core team role includes steering all regulatory aspects of development and leading subteams Serve as Subject Matter Expert on the current US regulatory environment and potential trends; recommend proactive approaches to regulatory issues Facilitate partnerships with key regulatory agency review staff Participate in due diligence with regulatory assessment and expertise Evaluate product dossiers for regulatory compliance and suitability for registration Proactive representation of RA for infrastructural processes and projects Lead or support infrastructural projects as assigned Represent the company at external functions to drive BI interests Communicate with regulatory authorities and industry associations Proactively seek contact with regulatory authorities and position BI as a trusted partner Maintain a balanced relationship with authorities Requirements Manager – Requirements
Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related Regulatory Affairs or equivalent/pharmaceutical industry experience OR Master’s in relevant scientific discipline with minimum seven (7) years related experience Excellent command of English, written and spoken Regulatory Affairs or equivalent pharma industry experience required Intrapreneurial spirit with rigorous compliance Ability to collaborate in a global organization and manage multiple projects Effective communication, negotiation, and interpersonal skills Ability to meet stringent time and quality demands Strong teamwork and change-driving ability Ability to handle high workloads and understand cultural differences Well-developed organizational capabilities Self-motivated Associate Director – Requirements
Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum five (5) years Regulatory Affairs strategy/execution experience OR Master’s in relevant scientific discipline with minimum ten (10) years experience Excellent command of English, written and spoken At least five (5) years in Regulatory Affairs roles, or equivalent in pharma Minimum two to three (2–3) years interacting with authorities (e.g., in new product development or complex maintenance projects, leadership of RA subteams) Knowledge of legal requirements for veterinary product approval Understanding of industry activity and regulatory trends Knowledge in relevant Regulatory Affairs areas; focus on safety and efficacy Regulatory affairs experience in animal health including prior FDA/CVM/EPA interaction Intrapreneurial spirit with rigorous compliance Proven ability to collaborate in a global organization across multiple projects Effective communication and ability to form productive relationships across disciplines and nationalities Ability to meet stringent time and quality demands; capable of developing systems for rapid outcomes Self-motivated with initiative and persistence Well-developed organizational capabilities Strong team player with BI mission alignment Ability to handle high workloads and understand cultural differences Desired Skills, Experience And Abilities Knowledge in international product registration and/or product development is desired Eligibility Requirements
Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older Our Company
Why Boehringer Ingelheim? With us, you can develop your own path in a company that values diversity and teamwork, and offers opportunities to contribute to patients and customers. We support our employees with programs for health and wellbeing, work-life balance, and career development. Visit our site for more information: https://www.boehringer-ingelheim.com
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