Associate Manager, Regulatory Affairs Biologics North America
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.
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.
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.
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.
Pharmaceutical Manufacturing
Legal
Full-time