Assoc. Manager​/Manager, Reg Affairs Bio

This position is accountable for activities required for regulatory filings and regulatory technical input for new product development, life cycle management, and compliance with local, state, and federal regulations applicable to veterinary biologics. Ensures and directs activities to ensure product supply and compliance for up to 3 USDA licensed manufacturing facilities. Provides regulatory guidance to manufacturing, R&D, Commercial Operations, and Supply Chain among others in multi-discipline teams supporting licensed products produced in the USA and registered in primary and emerging markets.

Corresponds and liaises on the company's behalf with the United States Department of Agriculture (USDA) Centers for Veterinary Biologics (CVB) and State Health Authorities. Represents the company during regulatory health authority inspections or correspondence. Ensures compliance with company policies and supports development and maintenance of regulatory and R&D procedures, work instructions, information management, and databases.

The Manager, Regulatory Affairs Bio is accountable for providing oversight and for executing activities required for compliance with the company's internal policies, local, state, and federal regulations applicable to veterinary biologics regulated by the USDA for new product development, licensed products compliance and life cycle management, multiple USDA licensed manufacturing facilities, and R&D facilities. This includes maintenance of regulatory dossier contents and company information management systems.

This position will provide technical regulatory guidance to manufacturing, R&D, Commercial Operations, and Supply Chain among others in multi-disciplined teams supporting new registration or continued registration and marketing of licensed products. The Manager, Regulatory Affairs Bio professionally corresponds and liaises on the company's behalf with the United States Department of Agriculture (USDA) Centers for Veterinary Biologics (CVB) and State Health Authorities.

The incumbent represents the company during regulatory health authority inspections and/or in responding to health authority questions. This role ensures compliance with company policies and supports development and maintenance of regulatory and R&D procedures, work instructions, information management, and databases. The position holder is expected to remain current regarding veterinary biologics laws, regulations, guidelines, policy and veterinary biologics issues to anticipate changes in the US, and international laws, regulations, guidelines and/or policy which may impact the Company and recommend appropriate action to protect Company interests.

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.

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.

• Prepares, reviews, and provides oversight for timely, complete, and accurate submissions to health authorities based on sound scientific information and data required for…