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.
• Responsibility to evaluate product dossiers for regulatory compliance and suitability for registration.
• Pro-active representation of RA for infrastructural processes and projects.
• Responsible for the successful update of regulatory tools as defined.
• Lead/support specific infrastructural projects as assigned.
• Active representation of company at external functions in order to drive agenda with BI best interests in mind.
• Communication interface and influencer with the veterinary regulatory authorities and industry associations.
• Responsible for proactively seeking contact with regulatory authorities directly, as appropriate, and positioning BI as a trusted and innovative partner (key account management).
• Ensure a balanced relationship with the authorities.

Requirements

Manager

• 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.
• 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.

Associate Director

• 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.
• Excellent command of English language, both written and spoken.
• 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.
• Awareness of the industry/direct competitor's activities.
• Knowledge in relevant Regulatory Affairs areas.
• 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.
• Intrapreneurial spirit while being rigorous and disciplined with compliance requirements.
• Demonstrated ability to successfully 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 at all levels across disciplines and nationalities.
• Able to meet stringent time and quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes.
• Self-motivated with a high degree of initiative, commitment and persistence.
• Well developed organizational capabilities.
• 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.

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.