Associate Manager, US Reg Affairs Operations

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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Associate Manager, US Regulatory Affairs Operations is responsible for coordinating and preparing high quality US regulatory submissions required by local and federal agencies to maintain BI products on the market.

Duties & Responsibilities

• Mentors/trains team members and acts as decision maker in absence of line manager.
• Interfaces with federal, state, and local regulators as needed to ensure compliance is maintained, as well as develop strategic approach for filing.
• Prepares and submits regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, product import, pesticide state adverse event reporting, state licensing renewals, state product renewals, and tonnage reporting.
• Contributes to the development and implementation of processes and work instructions for internal use and use by outsourcing partners. 
• Understands and monitors regulatory trends; works with industry to influence legislation and guidance; informs the company of new guidelines, directives, and agency initiatives.
• Independently supports systems for product compliance and maintenance and supports key user responsibilities as applicable.

Requirements

• Bachelor’s Degree, preferably in science, plus five (5) years of relevant industry experience, of which two (2) years to include interactions with regulatory authorities.
• Regulatory Affairs or equivalent industry experience is required with Agency interactions.
• Intrapreneurial spirit while being rigorous and disciplined with compliance requirements.
• Demonstrated ability to successfully collaborate in a global organization and manage a full workload.
• Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines and nationalities.
• Ability to meet stringent time and quality demands.
• 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.
• AI Competencies.
• Accountability: Taking ownership for decisions and actions.
• Agility: Quickly acting with an open mind to face internal and external circumstances.
• Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.

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.