Boehringer Ingelheim Ames IA United States
2 weeks ago
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.
• *SR Specialist Description
Support all regulatory activities required by federal, state, local, and international laws, as well as internal policies for continued manufacturing, distribution, and sales of veterinary biologics. In a team environment, to provide logistical and tactical regulatory expertise to internal business partners and stakeholders.
To serve as main point of contact for Industrial Operations, Commercial Operations, and Research & Development (R&D) for regulatory aspects of the veterinary biologics portfolio supply chain defense and life cycle management (LCM).
To determine appropriate regulatory requirements, commitments and actions required to support maintenance and defense of existing licensed products and manufacturing sites. To actively participate with non-regulatory team members in integrating the regulatory perspective in project teams related to new product development or LCM.
To remain current with regard to domestic and international laws, regulations, guidelines and/or policy that may impact BIAH veterinary biologics and recommend appropriate action to protect the Company's interests. In accordance with applicable regulatory requirements and the registration plans, create and maintain abbreviated files for international regulatory submission and provides technical regulatory support to assist timely and efficient registration in all target markets.
• *Associate Manager 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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
• *SR Specialist Duties & Responsibilities:**
+ Support regulatory compliance of licensed biological products throughout their lifecycle, ensuring proper regulatory management of changes, deviations, exemptions, notifications, renewals, and geographic extension in close collaboration with Industrial Operations, Quality Assurance (QA), R&D, Pharmacovigilance (PV), Business Operations, Legal, and others.
+ Support responses to regulatory inspections and government inquiries (domestic and international)
+ Provide regulatory assessments for proposed business and manufacturing changes related to approved biological products in compliance with USDA and international guidelines and regulations
+ Provide regulatory expertise and advice, as appropriate, to other functions or interdisciplinary project teams (in-line product management, launch teams, etc.)
+ Review draft regulatory texts, appropriately comment and propose amendments to draft requirements in alignment with company needs.
+ Maintain work instructions and tools (records, schedules, reports, database, etc.) for timely and efficient management of regulatory activities.
+ Manage and provide oversight for assembly, review, formatting, circulation, approval, and submission of Outlines of Production, Special Outlines, and facility documents to the Center for Veterinary Biologics (CVB) to support compliance and variations
+ Support organization, archiving, and retrieval of regulatory documents and correspondence
+ Help to assemble and provide final QA review for electronic submissions to government agencies through government portal(s) including updating documents to required templates and compliance with electronic record keeping
+ Maintain regulatory databases, activities charting, and government submission and response tracking
+ Support maintaining the official regulatory archives
+ Circulate, compile comments, and provide quality review of internal Policy, Procedures, and Guidelines (PPG)
+ Provide support for miscellaneous project assignments as needed
+ Secure needed import and transport permits or authorizations as needed from local, State, Federal, or international regulatory authorities
+ Manage correspondence with State regulatory authorities
+ Coordinate with international regulatory colleagues on global initiatives for which US input is required
+ Supports regulatory compliance and ensures proper regulatory management of changes, deviations, exemptions, notifications, renewals, and geographic extension in close collaboration with other areas.
• *Associate Manager 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 escalate risks related to compliance, licensed products supply continuity, or licensed facility risks to Regulatory Affairs management and Stakeholders with proposed mitigation strategies.
• *SR Specialist Requirements:**
+ A Master’s degree from an accredited institution, preferably in area of science, with one (1) year of related industry or regulatory experience
+ Or a Bachelor's Degree from an accredited institution, preferably in area of science, with a minimum of two (2) years previous relevant industry or regulatory affairs experience.
+ In lieu of either degree, eight (8) years of relevant industry experience and three (3) years relevant regulatory experience.
+ Experience in the pharmaceutical, biologics and/or related industries or disciplines dealing with US local, state, and federal regulatory issues related to in particular those associated with product development, licensure, and maintenance, licensed manufacturing facilities and related industry matters.
+ Must have regulatory knowledge and expertise.
+ Experience interacting with USDA or other government agencies preferred.
+ Excellent communication (verbal and written), negotiation, organizational, and teamwork skills
+ Committed to performance with attention to details
+ Innovative problem solving skills
+ High level of computer skills, including proficiency in Microsoft Word, Excel, Adobe Acrobat
• *Associate Manager Requirements:**
+ Master’s degree from an accredited institution, preferably in area of biomedical science or other related science, with three (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 of relevant industry or regulatory experience; Or
+ In lieu of degree, ten (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.
+ Experience is 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.
+ Demonstrated understanding of regulations and processes or related immunology/vaccinology concepts as they apply to vaccine development and/or product maintenance.
+ 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.
+ Ability to formulate strategies for performing regulated activities based on advanced/in-depth knowledge of relevant regulations and guidance documents.
+ Independent problem detection and initiation of problem solving.
+ Recognized as an expert by internal and external clients including regulatory health authorities and acts as a resource for colleagues.
+ Ability to resolve issues, lead and participate in multi-discipline and multi-culture teams and render appropriate judgment in scientific, regulatory, and technical matters.
+ Conflict resolution and negotiation skills.
+ Excellent verbal and written communication skills.
+ Good interpersonal skills.
+ Respectful interactions with individuals with diverse views or backgrounds.
+ Fluent in English.
+ Role model BI Values, by always doing what you say, and saying what you think.
+ Make timely decisions with well-balanced analysis and intuition, particularly in tough situations.
+ Ruthlessly prioritize, then drive execution excellence through discipline and collaboration.
+ Actively give and seek feedback; leverage each other’s strengths to deliver results and develop every individual.
+ Search and respond to drivers of changes, through active experimentation.
+ Respectfully challenge the status quo and assumptions of your own and others based on data, with no political bias. Self-awareness of how proposals impact colleagues and other functions. Balance efficiency with effectiveness.
+ Quickly turn data into insights and insights into actions.
+ Learn with an open mind, and rarely make the same mistake twice.
+ Serve the needs of customers and patients by turning innovative ideas into business results.
+ Take smart risks by leveraging all possible opportunities - including resources and talents.
+ Demonstrate winning spirit through creating a can-do attitude and positive energy among others.
+ Deliver high quality results, despite challenging conditions.
• *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.
• *Who We Are:**
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
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.
• *Organization:** _US-Boehringer Ingelheim Animal Health_
• *Title:** _SR Specialist/Associate Manager, Regulatory Affairs Biologics_
• *Location:** _Americas-US-MO-Saint Joseph_
• *Other Locations:** _Americas-US-GA-Athens, Americas-US-IA-Ames_
• *Requisition ID:** _235445
Ames IA USA
SR Specialist/Associate Manager, Regulatory Affairs Biologics Ames jobs
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