Manager/Associate Director, Regulatory Affairs Pharmaceutical Safety & Efficacy

Description

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 several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

As the Manager/Associate Director, Regulatory Affairs Pharma Safety & Efficacy you will:

Act as Regulatory Affairs (RA) team member in projects as well as in program teams.
Understand pertinent regulations and evaluate impact on projects/existing products.
Implement sound regulatory strategies for assigned products/projects within the team and ensure regulatory compliance with regards to safety and efficacy.
Link the safety and efficacy regulatory team with internal stakeholders and external stakeholders (regulatory agencies).

Duties & Responsibilities

• 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.
• Works with more senior RA team members to 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.
• Together with more senior RA team members, participate in due diligence processes by providing input into the regulatory assessment and expertise.
• Participate in the evaluation of the product dossiers for regulatory compliance and suitability for registration.
• Representation of RA for infrastructural processes and projects.
• Responsible for the successful update of regulatory tools as defined.
• Support specific infrastructural projects as assigned.
• Representation of company at external functions in order to support Boehringer Ingelheim interests.
• Basic knowledge in relevant Regulatory Affairs areas and ability to understand pertinent regulations.
• Basic knowledge and understanding of regulatory legislation and requirements for the development and maintenance of veterinary products with a focus on safety and efficacy aspects.
• Supports successful and efficient development and approval of assigned projects for the innovative strategy of the business and enhanced freshness index.

Requirements

• Advanced degree preferred (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum 2 years related experience in Regulatory Affairs strategy/execution; or 10 years related experience, including 2 years in Regulatory Affairs
• At least 2 years in Regulatory Affairs positions, or equivalent in the pharmaceutical industry.
• Awareness of the legal requirements for approval of veterinary medicinal products.
• Awareness of product development activities.
• Awareness of the industry/direct competitor's activities.
• Excellent command of English language, both written and spoken
• Regulatory Affairs or equivalent pharma 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.
• Self-motivated.
• Well-developed organizational capabilities.
• Strong team player who is collaborative with the mission of BI.
• Ability to handle high workloads and understanding of cultural differences.

Associate Director - Additional Requirements

• Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) from an accredited institution with a minimum of five (5) years related experience in Regulatory Affairs strategy/execution; or Masters from an accredited institution in relevant scientific discipline with minimum ten (10) years & experience in Regulatory Affairs strategy/execution.
• At least five (5) years in Regulatory Affairs positions, or equivalent in the pharmaceutical industry.
• Must include a minimum of two to three (2 to 3) years conveying exposure to authorities (e.g. in new product development or complex maintenance projects, leadership ofRA subteams).
• Sound knowledge of the legal requirements for approval of veterinary medicinal products.
• Ability to understand and anticipate regulatory trends.
• Knowledge and established understanding of regulatory legislation and requirements for the development and maintenance of veterinary products with a focus on safety and efficacy aspects.
• Regulatory Affairs or equivalent pharma experience in animal health is required including prior FDA/CVM/EPA interaction.
• Able to meet stringent time and quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes.
• Knowledge in international product registration and/or product development is desired.

Desired Skills, Experience and Abilities

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.