
Regulatory Specialist II
Job Summary:
This position's primary responsibilities are to provide regulatory expertise, networking and advocacy with the main international, regional and local trade associations; assist on regulatory processes related to Anvisa; assist in meeting and exceeding all customer needs and expectations with respect to regulatory issues. Support QA team with the completion of customer’s technical questionnaires related to Food additives and ingredients/product safety and regulatory compliance. Assist on initial review of customer specifications. Helps with the development of standard operating procedures.
Essential Duties & Responsibilities:
- Apply regulatory expertise to actively participate in discussions within Anvisa and Trade associations that are directly or indirectly related to our business of food colors/ingredients.
- Coordinate and follow up both national and international product registrations, regulatory submissions and reports to ANVISA and MAPA, and implement necessary approach to speed-up process and bring clarity.
- Assist preparation and review of regulatory documentation for current or new products submission or registration/approval dossiers.
- Conduct regulatory watch and monitor major global regulatory changes and stablish correlated action plan to local needs.
- Create, maintain and update relevant regulatory database around compliance and labelling for R&D, QA and marketing departments.
- Provide regulatory recommendations for all NPD & new launches to support solving blocking points.
- Provide regulatory support in customer’s projects including product development, compliance, labelling and claims.
- Apply regulatory knowledge to make compliance decisions on products we manufacture.
- Learn multiple business units and manufacturing processes to make regulatory decisions.
- Serve internal and external customers and demonstrate good customer relations skills.
- Contribute to department goals, objectives and participate on cross functional.
- Interpret proposed rules and regulations in order to formulate the appropriate customer response.
- Build network within the business.
- Completion of customer documents specific to Regulatory compliance.
- Resolution of customer complaints related to Regulatory issues.
- Identification of sales restriction by market and/or region as dictated by Regulatory statutes.
- Provides product information to internal and external customers with respect to domestic and foreign regulatory requirements in the area of colors regulations and related laws.
- Reviews customer's specifications and determines company's ability to comply. Communicates compliance with appropriate parties.
- Reviews and makes necessary revisions to technical data sheets, safety data sheets, and other standard regulatory documents, as needed before submission to internal and external customers.
- Independently prepares documentation for new products and current events.
- Strong interpersonal and communications skills, and organizational and planning abilities needed to handle multiple tasks concurrently.
Education:
Graduation in Food Science or similar; Post Graduation or MBA desired
Experience in food/food ingredients/food additives regulatory Affairs is mandatory.
Experience in food colors/coloring preparations desirable.
Existing network or experience in working with Regulatory Authorities and National Authorities in Brazil will be an advantage.
Advanced English for daily use
Ability to work with international reporting
Minimum of 5 years in Regulatory
Important: 100% presential in Jundiaí/SP.
ABOUT SENSIENT COLORS:
Sensient Color Group is a leading developer, producer and supplier of natural and synthetic color systems for customers around the globe. The Company's high-performance products play a central role in the manufacture of foods and beverages, cosmetic and pharmaceutical colors and coatings, inks for commercial and consumer printers, and colors for agricultural uses, household cleaners and paper products. The Color Group is located in St. Louis, Missouri.
ABOUT SENSIENT TECHNOLOGIES CORPORATION:
Sensient Technologies Corporation is a leading global manufacturer and marketer of colors, flavors, and fragrances. Sensient employs advanced technologies at facilities around the world to develop specialty food and beverage systems, cosmetic and pharmaceutical systems, inkjet and specialty inks and colors, and other specialty and fine chemicals. The Company's customers include major international manufacturers representing most of the world's best-known brands. Sensient is headquartered in Milwaukee, Wisconsin.
As a dynamic and diversified global leader, we offer an excellent salary and comprehensive benefits package. For more information, visit our website at http://www.sensient.com
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