Assoc. Manager/Manager, Reg Affairs Bio

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.

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.

Requirements

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.

Manager Duties & Responsibilities

•    Prepares, reviews, and provides oversight for timely, complete, and accurate submissions to health authorities based on sound scientific information and data required for new product registrations. Submissions to health authorities must comply with company policies and procedures, domestic (e.g. USDA, NIES, State), and international regulatory requirements for markets where the product is to be registered or is registered (e.g. Canada, Australia, EMEA, EU, Japan).
•    May lead 1-2 people. If leading projects instead of people, will lead >4 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).
•    Defines worldwide regulatory requirements and regulatory strategy for new product registrations, licensed products and licensed manufacturing facilities.
•    Pursues, maintains, and disseminates in a timely manner related regulatory guidance/intelligence to manufacturing, R&D, and commercial teams with regards to interpretation of health authorities published guidance, and evolving domestic and international regulatory trends that impact new product registrations, USDA licensed products, and USDA licensed manufacturing facilities the USA (e.g. Change Control, Deviations, Outlines of Production, claim extensions, new product registration plans).
•    Ensures complete, accurate, compliant, and inspection ready regulatory archives (paper and electronic), databases, and company information management systems.
•    Seeks input from stakeholders, aligns with RA management, and provides oversight and guidance to RA support staff and other functions for updating Regulatory Document Management and Quality systems (e.g. BIRDS, DAVID, Idea for Con, etc.).
•    Develops with input from stakeholders, authors, implements, and assesses effectiveness of regulatory processes required to comply with federal, state, and local regulations and in compliance with company policies.
•    Develops professional and credible relationships with federal and state regulatory agency contacts.
•    Develops, interprets, and implements legislation and guidance in alignment with company priorities. Negotiate on complex scientific topics.
•    Represents RA on multifunctional R&D teams, manufacturing and QA led cross-function teams, due diligence teams, or others as assigned.
•    Maintains advanced/in-depth knowledge of relevant domestic and international health authorities regulations, policies, and guidelines.
•    Serves as regulatory subject matter expert regarding USDA and State regulations and regulatory trends.
•    Identifies potential regulatory issues, develops regulatory strategy, recommends actions, obtains RA management and core team agreement, and executes agreed strategy.
•    Communicates regulatory guidance and trends applicable to veterinary biologics, USDA licensed facilities, R&D facilities, and R&D project initiatives along with impact assessment.
•    Provides leadership, coaching, training, and development to a group of regulatory professionals, regardless of reporting structure, to provide solid succession planning for the future of the team.
•    Pro-actively escalates risks related to compliance, licensed products supply continuity, licensed facility risks, or R&D project risks, to Regulatory Affairs management with proposed mitigation strategies.

Manager Requirements

•    DVM or PhD in area of biomedical sciences or other related science with at least three (3) years’ experience in related industry preferred.
•    OR
•    Master’s degree from an accredited institution, preferably in area of biomedical science or other related science, with five (5) years of related industry or regulatory experience required.
•    OR
•    Bachelor's Degree from an accredited institution, preferably in area of biomedical science or other related science, with a minimum of eight (8) years of relevant industry or regulatory experience required.
•    OR
•    In lieu of degree, ten (10) years of relevant industry experience with five (5) years of relevant regulatory experience required.
•    Exceptional written and verbal communication skills include ability to persuasively communicate on scientifically complex topics.
•    Effective interpersonal skills with the ability to work collaboratively in a multi-cultural team-based setting; flexibility; achievement-oriented with appropriate concern for quality and efficiency are highly desirable qualifications.
•    Excellent analytical and problem-solving skills; scientific and/or technical knowledge pertaining to vaccine efficacy, safety, purity, and potency.
•    Computer literacy required.
•    Ability to formulate strategies for performing regulated activities related to veterinary vaccine development, registration, and life cycle management.
•    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.
•    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 respectful and professional feedback based on data and not assumptions; leverage each other’s strengths to deliver results and develop every individual.
•    Search and respond to drivers of changes, through active experimentation.
•    Professionally challenge the status quo and assumptions of your own and others, with data and 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, seek to understand genesis of existing practices, 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.
•    Fluent in English.
•    Willingness to travel, both domestic and internationally <10% of the time (overnight may be included).

Assoc. 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.

Assoc. Manager 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.
• Willingness to travel.