Regulatory Affairs Manager

Relocation Assistance Offered Within Country

160128 - Topeka, Kansas, United States

Responsible for ensuring compliance by Hill’s Pet Nutrition with regulations and statutes concerning research and development, manufacturing, distribution, marketing and sales of Hill’s products in the United States and where international regulations and statutes may impact U.

S. produced products. Possess technical and regulatory expertise (for North America regulatory system and internal HQ regulatory processes).

Oversee and develop an internal regulatory team focusing on market access execution activities including packaging development compliance, domestic product registration and export market product registration support.

Work independently and collaboratively in research activities, showing and sharing knowledge of pet food regulations. This position will also serve as the technical and regulatory expert (for packaging compliance and registration management) leading the go-to-market regulatory team.

Additionally, this position will lead strategic efforts and execution of Pet Food Label Modernization.

Demonstrate strong knowledge of regulations that impact U.S. products and the global regulatory environment. This individual will also monitor and update the business on relevant changes to regulations, possibly represent Hill’s Pet Nutrition on trade association committees and will ensure new and efficient processes are developed and documented to address future issues and will identify initiatives and efficiencies to drive process improvement.

This individual will also have responsibility for managing and developing internal regulatory staff.

Principal responsibilities :

Regulatory Product Lead (Domestic Product Registration) :

• Lead U.S. state registrations to ensure complete, accurate, compliant, and timely submissions;
• Build and leverage relationships with state and federal regulators and lead the creation and response to product challenges.
• Lead creation and review of relevant Standard Operating Procedures / Work Instructions and policy guidelines (update as needed) including Regulatory POVs in order identify opportunities for improvement and streamlining of technical processes.
• Monitor, evaluate, and report on regulations and registration actions involving pet food, including state and federal regulatory issues / changes.
• Monitor broader relevant regulatory environment, including proposed changes which may impact Hill’s operations and their products.
• Advise and make recommendations back to the business as to impact.
• Stay abreast of international projects that may impact U.S. regulatory environment or U.S. manufacturing.

Regulatory Packaging Compliance Lead (Global Packaging Compliance)

• Lead regulatory packaging compliance team and serve as the subject matter expert for all aspects of packaging compliance including export market packaging requirements.
• Identify claims, regulatory compliance and packaging content issues; lead / proffer alternatives to comply with regulatory guidelines while supporting business needs.
• Where efficiencies can be developed and where cross-functional regulatory relationships can be improved, propose strategies and enact them.
• Utilize regulatory experience / expertise to provide input and influence business / technical / policy decisions.

Internal and External Relationship Building :

• Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners : Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business;
• Ensure programs are aligned with overall business strategies of various clients;
• Interpret the impact of ongoing developments in the regulatory environment for both clients and staff;
• Develop / maintain / strengthen relationships and participation in key U.S. trade associations, including PFI and AFIA and push key initiatives in support of Hill’s;
• Display leadership through active participation and influence in trade association meetings to benefit Hill’s and the pet food industry as a whole;
• Report back relevant information that may affect Hill’s products, operations or decision-making;
• Drive regulatory understanding within key internal business partners such that it facilitates continuity of business, accomplished through creation and presentation of critical information to senior business leaders.

People Management & Process Capabilities :

• Lead regulatory team personnel (Market Access Execution Go-To-Market team), including mentoring, training, coaching, and development of regulatory staff.
• Responsible for achieving independent and team results, developing internal efficiencies, and ensuring team member responsibilities are understood and direct reports and teams are accountable for their performance and corresponding impacts.
• Facilitate sharing of technical knowledge within the regulatory team.
• Drive a culture of process improvement, regularly evaluating systems and approaches to ensure maximum efficiencies while also working to minimize overall risk to the business.
• Manage Regulatory project teams and report out to leadership as warranted.
• Education / Experience Requirements

Required Qualifications :

• Bachelor's degree in Policy, Animal / Food Sciences, or equivalent;
• Minimum 5 years in Regulatory Affairs within any of the following industries : pet food, food, OTC drugs, medical devices or pharmaceuticals;
• Minimum of 5 years preparing regulatory registration submissions, packaging compliance review, product claims review, or analyzing and interpreting product regulations or overseeing such work.

Preferred Qualifications :

• Master’s or PhD in business, policy, animal sciences or DMV;
• People management experience;
• Minimum of 5 years interpreting and applying AAFCO regulations / guidelines and applicable pet food related U.S. (e.g.

FDA, CVM, USDA) and foreign regulations.

Compensation and Benefits

Salary Range $128,000.00 - $150,000.00 USD

Pay is based on multiple non-discriminatory, individualized factors including but not limited to experience, job-related knowledge and education, skills and office / market location.

In addition to base salary, salaried employees are eligible for annual discretionary bonuses, profit-sharing and, for Executive-level (salary grade 16 and above) roles only, long-term incentives in the form of Restricted Stock Units and / or Stock Options.

Subject to the terms and conditions of the applicable benefits plans then in effect, all salaried employees are also eligible for a competitive benefits package which includes :

• Insurance : Employees (and their eligible dependents) are eligible to participate in Company-sponsored Medical, Dental, Vision, Basic Life Insurance, Accidental Death & Dismemberment and Disability insurance plans.
• Retirement Plans : Employees are eligible to enroll in Colgate's 401(k) plan, which provides for company matching contributions subject to eligibility requirements
• Vacation / PTO : Employees receive a minimum of 15 days of vacation / PTO leave annually
• Paid Holidays : Employees receive a minimum of 13 paid / floating holidays annually
• Paid Sick Leave : Based on location and consistent with applicable state and local law, employees receive a minimum of 40 hours of paid sick leave on January 1st of each year
• Paid Parental Leave : Eligible employees may take up to eight weeks of paid parental leave and 12 weeks of unpaid leave (varies for employees with fewer than 12 months of service and is subject to hours worked requirements)
30+ days ago