Summary / Purpose of Position:
The Sr. Global Regulatory Affairs Lead will work cross functionally with teams to support the global regulatory needs of a robust product pipeline and product maintenance for registered products. The role will be tasked with advancing and supporting new product innovations by providing clear expectations on data and filing requirements for pipeline projects in conjunction with R&D team members, as well as ensuring registered products and their labels are maintained and distributed in a manner that meets regulatory and supply requirements. Additionally, the role will ensure United Animal Health has a cogent regulatory strategy and registrations are completed in accordance with appropriate regulations and commitments to global regulatory authorities.
The Sr. Global Regulatory Affairs Lead will manage a support team that includes direct reports, distributors that the ability to perform some regulatory responsibilities, and UAH team members in other functions with regulatory experience and responsibilities. The role requires an innovative problem-solver who is passionate about customers and innovation and is able to work with other departments collaboratively.
Primary Job Responsibilities / Duties:
- Ensure that United deliverables are completed in accordance with appropriate regulations and commitments to global regulatory authorities
- Develop and implement global strategies that result in unfettered and continued supply to customers for registered products
- Ensure high quality product labels are developed and continue to reflect registration and importation requirements
- Ensure product labels represent pertinent product dossier content, manufacturing conditions, and regulatory and importation requirements
- Pharmacovigilance requirements are met for competent authorities when and where required
- Develop and implement global regulatory strategies that result in improved time to approval for new products
- Build and maintain working relationships with key external regulatory authority personnel
- Work with animal health industry associations and regulatory agencies to ensure market access and/or approval for United products.
- Achieve successful and timely product registrations by fostering collaborative partnerships with local, regional, and global stakeholders from regulatory affairs, R&D, manufacturing, and product management, and sales.
- Recommend registration and marketing opportunities based on assessment of regulatory knowledge, strategic fit for consumer and business impact, complexity, and time to market.
- Develop and maintain relationships with key external global regulatory stakeholders, distributors, and CROs.
- Inform R&D and manufacturing sites of regulatory and facility inspection requirements.
- Define and communicate regulatory requirements (with a focus on manufacturing and quality attributes) to internal teams with varying levels of technical understanding to ensure products are produced, released, and labeled to meet regulatory and importation requirements.
- Work collaboratively with Marketing & Product Management, R&D and Sales to ensure a holistic, integrated product development and marketing plans take into account global regulatory requirements.
- Act as a brand steward for all product innovation and established products; role model with uncompromising passion for UAH innovation and product standards, quality, and compliance.
- Stay on the cutting edge of new regulatory developments and innovation in animal health, keeping an eye toward the most relevant issues in health, nutrition and sustainability.
- Effectively communicate customer engagement strategy and innovation priorities across the organization, relaying department and organizational opportunities and objectives, and identifying potential barriers as appropriate.
- Build, retain and motivate a team of regulatory affairs professionals with regulatory affairs knowledge and responsibilities, as well as external consultants and distributors
- Build effective relationships with cross functional teams, senior leadership and customers.
- Advise leadership team on key issues, make recommendations on business decisions, advise on risks and threats.
- Ensure high quality of team output, especially as it pertains to dossier compilation and post approval updates, and label composition.
- Set aggressive, achievable goals, tied to long-term goals of company and monitor performance against goals.
- Establish and monitor KPI metrics to drive success and advancement of UAH reputation as an innovator and a company of high integrity and compliance.
- Carry out managerial responsibilities which include interviewing, hiring, and training employees. planning, assigning, and directing work. appraising performance, rewarding and disciplining employees addressing complaints and resolving challenges.
- Drive employee engagement/experience by establishing communication channels, training, mentoring and supporting recognition programs to attract and retain the key people resources needed to support the organization; build a robust talent pipeline.
- Develop great people and a great team by developing and refining team structure.
- Ensure department and projects are run profitably, efficiently, and with clear ROI.
Additional Job Responsibilities / Duties:
- Leadership – Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Business Acumen – Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals. Develops and works within approved budget; Contributes to profits and revenue; Optimizes organizational resources.
- Strategic Planning – Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
- Cost Consciousness – Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
- External Awareness- Understands and keeps up-to-date on local, national, and international policies and trends that affect the organization and shape stakeholders’ views; is aware of the organization’s impact on the external environment.
- Innovation – Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.
- Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
- Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; designs workflows and procedures.
- Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Project Management – Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
- Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed.
- Interpersonal Skills – Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
- Oral Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
- Written Communication – Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
- Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- Other duties and responsibilities, as assigned
Typical Work Environment:
- Execution of this role may be completed in a hybrid manner; in-office and/or remote
- Work is conducted in a temperature-controlled office.
- Travel may be required based upon business need
Minimum Job Qualification Requirements:
Education / Training:
- Master’s required. PhD, DVM or, relevant field or job experience is highly desirabl
- A minimum of 12-15+ years of regulatory affairs experience in animal health
Specialized Job / Technical Knowledge:
- Knowledge of animal agriculture industry preferred
- Knowledge of product development, innovation, management and/or research disciplines
Non-Technical Skills and Abilities:
- A strong understanding of regulatory affairs, product innovation, and strategic account management.
- Proven track record of success in regulatory affairs innovation and product maintenance
- An individual with creative orientation who is able to apply novel approaches to keychallenges.
- Demonstrated ability to influence outcomes with regulatory agencies with respect to regulatory path, product labels, and data requirements
- Demonstrated disciplined approach to analyzing, presenting, and taking ownership of results.
- Relevant experience balancing both the strategic and tactical challenges of growing a business.
- Ability to identify, recruit and retain strong talent. Experience motivating cross functional teams and building consensus with clear objectives.
- Proven ability to create, implement, and own strategic development of business plans with the objective of growing a business.
- Understanding of the dynamics required to work in a consolidating industry where customer dynamics drive the business.
- Demonstrated ability to adapt to change quickly by being forward thinking and role modeling for others to follow.
- Excellent flexibility to adjust to changing priorities
- Champion of UAH Culture
Licenses / Certification: None
Physical Requirements: Ability to lift 50 or more pounds periodically
Safety Requirements: Follow all company safety procedures and safety regulations