Assoc. Manager, Reg Affairs Bio

Boehringer Ingelheim; Athens (GA); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid work environment

Job summary

Boehringer Ingelheim Animal Health USA in Athens, GA seeks a Regulatory Affairs professional to oversee regulatory filings and lifecycle management for licensed veterinary biologics. You will collaborate with Manufacturing, R&D, and Commercial Ops to ensure timely submissions and inspection readiness across US facilities.

The role requires mastery of 9CFR and CVB guidance, strong communication, and the ability to mentor teams while maintaining regulatory archives and coordinating with federal

Qualifications

• Master's or Bachelor's degree in biomedical science or related field with 3–5 years of regulatory experience.
• Experience with US regulatory agencies and writing technical submissions.
• Fluent in English and able to communicate complex scientific topics.

Responsibilities

• Ensure timely and quality submissions based on scientific information for compliance with 9CFR and USDA guidance.
• May lead 1–2 people or more on global product registration projects and life cycle management.
• Provide regulatory guidance to manufacturing, R&D, and commercial teams on interpretation of regulations and guidance.
• Maintain regulatory archives and submission tracking, oversee document management systems.
• Develop and assess effectiveness of regulatory processes to comply with federal, state, and local regulations.
• Build professional relationships with federal and state regulators and negotiate on scientific topics.

Skills

Regulatory affairs

USDA/CVB knowledge

Vaccine regulatory

Regulatory strategy

Cross-functional collaboration

Education

Master's degree in biomedical science or related field

Bachelor's degree in biomedical science or related field

10 years of relevant industry experience in lieu of degree

Tools

BIRDS

DAVID

Job description

Description

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.

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

• Ensures timely and quality submissions based on sound scientific information required to maintain compliance with the 9CFR and related USDA published guidance in collaboration with manufacturing, quality assurance, quality control, and R&D.

• May lead 1-2 people. If leading projects instead of leading people, will lead >2 global new product registration projects requiring more advanced technical knowledge and/or will be responsible for independently supporting a global supplier of products and related life cycle management projects(i.e. BI manufacturing sites supplying >60 products to >40 countries).

• Actively pursue, maintain, and disseminate timely regulatory guidance/intelligence to manufacturing, R&D, and commercial teams with regards to interpretation of existing 9CFR regulations, CVB published guidance, and evolving regulatory trends that impact licensed products and BI licensed manufacturing facilities in the USA (e.g. Change Control, Deviations, Outlines of Production, claim extensions).

• Assure complete and compliant regulatory archives and databases/submission and response tracking. Provide oversight and guidance for updating Regulatory Document Management and Quality systems (BIRDS), DAVID, Idea for Con, etc.).

• Develop, document, implement, and assess effectiveness of regulatory processes required to comply with federal, state, and local regulations and in compliance with BI policies.

• Actively develop professional relationships with federal and state regulatory agency contacts using sound scientific principles and strong communication skills (verbal and written); engage in development, interpretation, and implementation of legislation and guidance in alignment with BI business needs and policies; ability to negotiate on complex scientific topics.

• Maintain advanced/in‑depth knowledge of relevant regulations, policies, and guidelines. Serve as regulatory subject matter expert regarding USDA and State regulations and guidance applicable to licensed veterinary biologics and licensed facilities.

• Provide coaching, training and development to regulatory professionals and stakeholders in order to provide solid succession planning for the future of the team.

• Pro-actively escape risks related to compliance, licensed products supply continuity, or licensed facility risks to Regulatory Affairs management and Stakeholders with proposed mitigation strategies.

Requirements

• Master's degree from an accredited institution, preferably in area of biomedical science or other related science, with 3 years of related industry or regulatory experience OR

• Bachelor's Degree from an accredited institution, preferably in area of biomedical science or other related science, with a minimum of five (5) years relevant industry or regulatory experience OR

• In lieu of degree, 10 years of relevant industry experience and 5 years relevant regulatory experience.

• Must have knowledge and experience developing and successfully executing strategies in a regulated environment or the market impacted by veterinary biologics; demonstrated understanding of regulations and processes or related immunology/vaccinology concepts as they apply to vaccine development and/or product maintenance.

• Experience preferred in interacting and communicating with major regulatory agencies in all stages and proven ability to discuss scientific aspects of the program with those agencies.

• Must have strong business acumen and demonstrate diplomacy in all interactions.

• Independent and multidisciplinary problem detection and initiation of problem solution.

• Direct knowledge of regulatory requirements for demonstration of safety and effectiveness, including principals of study conduct, statistics and design preferred.

• Professional customer focused approach.

• Prioritizes, manages time, and works independently to meet or exceed agreed upon projects/timelines.

• Knowledge of US and international regulatory requirements.

• Recognized as expert by clients and acts as a resource for colleagues.

• Ability to resolve issues, lead teams and render appropriate judgment in scientific, regulatory and technical matters.

• Conflict resolution and negotiation skills, respectful interactions with individuals with diverse views or backgrounds.

• High degree of detail orientation and excellent verbal and written communication skills; good interpersonal skills; does not hesitate to actively participate and provide regulatory assessments in meetings.

• Strong conflict resolution and negotiation skills. Ability to resolve issues, lead and participate in multi-discipline and multi-culture teams and render appropriate judgment in scientific, regulatory, and technical matters.

• Excellent verbal and written communication skills; good interpersonal skills;

• Display accountability and model BI values by always doing what you say, and saying what you think.

• Fluent in English.

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.

JOB ID

38380

Job function

Regulatory Affairs

Career level

Experienced professionals

Organization

Boehringer Ingelheim Animal Health USA

Working time

Full-Time

Job flexibility

Hybrid

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law