Manager, RA Pharma Safety & Efficacy

Boehringer Ingelheim is a pharmaceutical company developing and delivering products to patients and customers worldwide. The Manager, RA Pharma Safety & Efficacy provides US regulatory strategy for assigned veterinary pharmaceutical development and lifecycle-management projects, represents regulatory affairs in global project teams, and manages FDA meetings, submissions, dossiers, labeling, and stakeholder communications.

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

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

Benefits

Hybrid work arrangement

Opportunities to collaborate internationally

Visibility and opportunity to directly contribute to the company's success

Support for a healthy working environment

Meaningful work

Mobility opportunities

Networking opportunities

Work-life balance support

Competitive compensation and benefit programs

Company

Pharmaceutical company for human and animal health.

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

https://www.boehringer-ingelheim.com/

Founded in 1885

10001+ employees

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

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

Ability 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

Ability to handle high workloads and understanding of cultural differences

Well-developed organizational capabilities

Self-motivated

Must be legally authorized to work in the United States without restriction

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.

Masters in relevant scientific discipline with minimum seven (7) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry.

Required skills

Regulatory Affairs, Pharmaceutical Industry, Regulatory Compliance, Product Labeling, Regulatory Submissions

Experience

2+ years