Sr. Manager, Regulatory Affairs Americas

Senior Manager of Regulatory Affairs, Americas

Glanbia  

Join this dynamic team focused on delivering better nutrition for every step of life’s journey 

The Opportunity 

Oversee the regulatory aspects of the manufacture, sales, and distribution of Glanbia Nutritionals dairy and non-dairy products in the Americas. As a subject matter expert, serve as a key point of contact for customers and commercial stakeholders on regulatory topics. Perform assessments of products commercialized in or distributed to North American and South American markets. Liaise with government authorities, agencies, and consultants to track current and emerging regulations impacting the business. Manage queries and provide regulatory updates and communication to internal and external stakeholders.

Ensuring that the company complies with all applicable export control laws and regulations and import regulations in the territories where our products are sold. This includes a variety of tasks related to importing and exporting goods across borders, including products and manufacturing sites registration in foreign jurisdictions, when needed.

Essential Functions

• Provide regulatory expertise in the region, and serve as the regional expert for all regulatory matters.
• Lead the US regulatory affairs and experts/specialists team, providing guidance and mentorship, as well as maintaining budget requirements and targets.
• Perform regulatory assessments of new products commercialized in the North and South American markets, and lead projects related to new product registrations in the region, with the ability to liaise with government authorities and agencies to successfully drive final approvals.
• Serve as a subject matter expert for regional regulatory topics. Work with government authorities and agencies ranging from simple to complex regulatory tasks and issues.
• Perform horizon scanning for emerging regulations impacting the business.
• Manage regulatory queries and provide regulatory updates and communication to internal and external stakeholders.
• Develop and distribute regulatory guidance to internal and external stakeholders, including review of market regulations.
• Manage the contracting of third-party regulatory consultants. Manage and track queries to external regulatory consultants including costs.
• Provide guidance for the development and implementation of material specifications to meet regulatory requirements (e.g., nutritional, allergen, microbiological and chemical contaminants).
• Oversee the effective and efficient process for the completion of customer regulatory questionnaires and queries.
• Trouble shoot commercialization issues relating to regulatory topics. Analyze trends and establish leading indicators to minimize impacts.
• Manage export global compliance for all GN products and facilities outside of the US.
• Collaborate with logistics teams to ensure proper documentation and adherence to export regulations.
• Assist in resolving issues related to customs clearance and duties.
• Apply foreign trade commerce policies, embargoes, economic sanctions, national security, etc.
• Monitor applications for and maintenance of all GN manufacturing sites registrations worldwide (FDA, CFIA, USDA, EU, etc.), including site registrations for export compliance in both dairy and premix.
• Attend Regulatory and Commercial meetings and other meetings as deemed appropriate.
• Participate in proactive team efforts to achieve departmental and company goals.
• Provide leadership to others through example and sharing of knowledge/skill.
• Perform other duties as assigned or needed.

 The Skills you will bring to the team

• Minimum Bachelor of Science (BS) or equivalent degree in the field of science and technology or Law and ten (10) years of related management experience.
• Knowledge and/or training in Regulatory Affairs.
• Experience in Nutritional or Dietary supplements, Infant formula and FSMP (Food’s for Special Medical Purposes) products, Clinical Nutrition, and Food and Beverage industry is preferred, specifically in a regulatory capacity.
• Experience working with government authorities and agencies in a regulatory capacity, as it relates to new product registrations for foods/beverages/dietary supplements/nutritional products, as well as regulatory tasks and issues.
• Ability to respond to common inquiries or complaints from customers and other third parties, regulatory agencies, or members of the business community.
• Ability to effectively present information to corporate leadership.
• Ability to solve practical problems and deal with concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to read and comprehend complex instructions, correspondence, and memos. Ability to convey in writing concise and understandable correspondence and instructions. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
• Ability to handle multiple projects simultaneously.
• Ability to prioritize, organize, and delegate assignments.
• Leadership skills.
• Strong understanding of international trade compliance, export control regulations, including the Export Administration Regulations (EAR), and the Office of Foreign Assets Control (OFAC) regulations.
• Familiarity with SAP (an asset).
• Regular overnight travel (up to 25%).

Where and how you will work  

This is a work from home position in the U.S.

What we would like to offer you!  

The opportunity to develop your career on a global stage, continuous learning through an on-demand learning platform, and a competitive compensation package including staff discounts, generous family leave policy, health & dental plan, competitive salary, 401K.  

About Glanbia  

Glanbia is a better nutrition company with three divisions: Performance Nutrition, Health & Nutrition and Dairy Nutrition. Collectively and with our partners we offer an incredible breadth of expertise in nutrition. We employ a team of 5800 people, work with global food and beverage companies, and sell our award-winning and market-leading brands and ingredients in more than 100 countries worldwide

At Glanbia, we celebrate diversity, because we know that our individual strengths make us stronger together. We welcome and encourage interest from a variety of candidates, we will give your application consideration, without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.

At Glanbia, our culture celebrates individuality, knowing that together we are more.