Sr. Specialist, Reg Affairs NAM

Job Description

Sr. Specialist, Reg Affairs NAM - Remote

 
It’s an exciting time to be part of IFF, we are looking for our next Senior Analyst of North America Global Regulatory Affairs (GRA) to become a part of our industry-leading North America team. Are you passionate about building deep relationships and developing a growing sales portfolio with an industry leading customer? Do you aspire to be part of a team that drives big wins for the organization? Would you love to work for a company that is transforming the everyday? If the answer is yes, this may be your next career step!

This role will be responsible for completing the regulatory work for the Nourish business and applicable joint ventures, with a focus on protein ingredients, for the US and Canada for primarily food but also feed applications. The Senior Analyst is responsible for regulatory document development and compilation for registration/market access as well as pre- and post-launch compliance activities with a focus on the Protein Solutions portfolio.

Job duties include, but are not limited to the following:  

• Responsible for overall management of the Protein Solutions product portfolio.
• Read and interpret US and Canadian regulations; draft submissions/documentation to support product safety for US (e.g., GRAS) and Canada 
• Serve as the main point of contact for the Protein Solutions business, which includes food and feed applications.
• Collaborate with other functions including Quality, R&D, and the business
• Meet with protein ingredient design and application related R&D teams to provide regulatory guidance. 
• Submit Prior Notices for the importation of samples into the US
• Maintain a drug master file (DMF)
• Provide regulatory support to non-Protein Solutions businesses such as Food Enzymes, Dairy and Cultures, and Grains Processing
• Contribute to global regulatory compliance programs for IFF marketed products in conjunction with global GRA team and product management.
• Update Registration List to communicate the status of the US and Canadian regulatory projects, participate on GRA calls and working groups related to global regulatory work.
• Participate in projects regarding improving regulatory processes within GRA
• Upload and maintain documentation and improve documentation of U.S. and Canadian

Required Education:

• The  position requires at least Bachelor’s degree in Biology or a closely related scientific field and preferably with at least 4 years of relevant work experience or Masters with 2 years of relevant work experience in several aspects of regulatory processes. 

Additional experience requirements include:

• Experience in preparing clear, accurate regulatory submissions/dossiers or similar documents (e.g., technical reports/scientific papers, risk assessments).
• Experience successfully impacting product introductions by providing regulatory & safety guidance and/or successfully influenced decisions to implement change.
• Experience in interaction with and education of regulatory agencies and trade associations and track record in product clearance/registrations and regulatory advocacy. 
• In depth knowledge and recognized for leadership & innovation in managing regulatory submissions to FDA and Health Canada. 
• Successfully implemented complex/controversial regulatory policies and strategies, and/or systems to improve regulatory data communication.
• Demonstrated forming influence on the department (can be in non-technical/scientific manner) and/or strong impact on the success of future products and processes.
• Demonstrated continuous learning mindset and flexibility to expand expertise into new industries, applications, and jurisdictions.
   

We are a global leader in taste, scent and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.