Associate Director, Regulatory Affairs Pharma Safety & Efficacy - Animal Health

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, Act as Regulatory Affairs (RA) core or sub team 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, development and business activities in accordance with the strategic plan of the company.

• 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.

• 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 of RA 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…