AD, Regulatory Affairs Biologicals

Regulatory Affairs Expert For Veterinary Biologics

An expert resource in all regulatory aspects of veterinary biologics for canine, feline, poultry, cattle, swine, bio-therapeutics, Veterinary Public Health, etc. Serves as the main regulatory contact for global R&D project teams, manufacturing sites, for International markets to ensure new registrations, variations, geographic extensions, and licensed product stewardship in accordance with the company's global strategic objectives. Provides expertise for global product development with International Markets as Target Countries in addition to support correspondence and applications to the Agencies from the Intl. Markets. Represents independently develops global regulatory strategy and ensures execution for regulatory activities for International markets. This role provides leadership for guiding the company through complex regulatory paths through early research, product development and stewardship directly impacting sales.

Duties & Responsibilities:

• Independently develop global regulatory strategies in alignment with global business and R&D objectives. Ensure and guide execution by leveraging personal expertise, industry and company networks, and in-depth understanding of global regulatory requirements.
• Serve as expert resource for global regulatory, R&D, and Business Unit groups. Understand and communicate current and anticipated global regulatory environment and trends. Provide leadership/guidance/training within the regulatory and to other departments relative to regulatory strategy, execution, compliance, submission requirements, and project milestone interdependencies and time lines. Must be proactive in anticipating global regulatory and business needs and effectively communicating needed actions to internal and external stakeholders.
• Independently advise global and local new product development teams, manufacturing/OPU site leadership, Business Development, Commercial Operations, and other stakeholders on scientific/technical information necessary for global and local regulatory submissions for new product registrations, license product defense, claim extensions, and securing product supply or compliance, this includes evaluation and guidance related to safety, efficacy, Part2/CMC/Outlines of Production, analytical methods, animal origin ingredients, environmental risks assessments, bio-containment requirements, product stability, and technical labeling requirements. Strategies include time to market optimization, risk mitigation, and differentiation from competition with customer relevant claims.
• Proactively partner with global regulatory teams to influence regulatory policy on behalf of company needs. Understand and monitor global and local industry regulatory trends and work to inform the company of new requirements, guidelines, directives, and agency initiatives. Understand/monitor industry regulatory trends and work to inform the company of new guidelines, directives, and agency initiatives.
• Develop professional and credible relationships with federal and state regulatory agency contacts using sound scientific principles and professional effective communication skills (verbal and written). Engage in development, interpretation, and implementation of legislation and guidance in alignment with company priorities. Negotiate on complex scientific topics.

• Oversee and participate in developing, authoring and reviewing country, site, departmental processes and SOP's for activities relevant to this position and perform special projects as assigned. Provides leadership, coaching, training, and development to the a group of regulatory professionals, regardless of reporting structure, in order to provide solid succession planning for the future of the team and leading to increased team efficiency.

Requirements:

• Prefer DVM or PhD in area of biomedical sciences or other related science including > 8 years of relevant industry experience.
• Master's degree from an accredited institution, preferably in area of biomedical science or other related science, with > 10 years of related industry or regulatory experience.
• Bachelor's Degree from an accredited institution, preferably in area of biomedical science or other related science, with a minimum of 15 years of relevant industry or regulatory experience.
• Exceptional written and verbal communication skills including ability to persuasively communicate on scientifically complex topics.
• Effective interpersonal skills with the ability to work collaboratively in a multicultural 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 multiculture 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

Accountability:

• 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.

Agility:

• 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.

Intrapreneurship:

• 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.
• Willing to travel, both domestic and internationally up to ten (10) percent of the time

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.

Desired Skills, Experience and Abilities: