Regulatory Affairs Specialist in Lakeland, Florida at TREATT NORTH AMERICA

JOB SUMMARY

Regulatory ensure product safety and efficacy by interpreting and giving guidance on the impact of any regulatory change and ensuring compliance is maintained. It is the responsibility of the Regulatory Affairs Specialist to provide support to make sure that products and services carried out by Treatt are within regulatory and legal guidelines. This applies to customers.

DUTIES & RESPONSIBILITIES

• Completion of Customer Questionnaires and product questions, ensuring that they have begun the process and been acknowledged within 24 hours of receipt, prioritizing where necessary.
• Preparation of Product Documentation for customers based on current regulations.
• Effectively and efficiently communicate and cooperate with internal and external customers on problem solving and projects which require input.
• To provide product support to the commercial team.
• ERP Functions (Amending or addition of regulatory data, assignment of documents or other as required)
• Provide cover for other tasks performed in the Regulatory Department (as detailed in training matrix)
• Contribute to continuous improvement in the Regulatory Team (e.g. suggestions on improvements in quality and efficiency etc.)
• Actively promote a Customer Centric Culture across the business, leading by example
• Fulfil the role of effective team player, supporting colleagues, sharing knowledge, collaboration with similar positions within the industry and undertaking other duties / tasks, appropriate to function at the discretion of line management, to the benefit of the department and the business.
• Undergo training in areas specific to Treatt Limited business as required.
• Act in the best interests of Treatt Limited at all times
• Any other functions related to the Regulatory Department Activities.

EDUCATION & TRAINING

Associate degree, or HS Diploma with 5 yrs. industry related experience in customer service or regulatory.

KNOWLEDGE & EXPERIENCE

• Knowledge in current Good Manufacturing Practices (GMP).
• Knowledge in HACCP.
• Familiarity with JD Edwards/SAP Software.
• Familiarity with Microsoft Applications.
• Familiarity with 3rd party portals.
• Strong computer skills are essential.
• Strong communication skills, verbal, written and oral, are an absolute necessity.
• Individual should be effective working from a team approach.
• Demonstrated organizational skills.
• Proven ability to effectively follow written and verbal instruction.
• Self-directed; possesses ability to work well independently.