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Regulatory Affairs Specialist

Company: Platinum Performance
Location: Santa Maria
Posted on: December 1, 2019

Job Description:

Company Description Platinum Performance is a premier nutritional focused Animal Health company founded in 1996 out of a world renowned equine veterinary hospital on the Central Coast of California. Today Platinum Performance serves most equine veterinary practices across the United States and abroad. Platinum Performance was founded on the belief that wellness and nutrition are the foundation of exceptional health for both people and the animals we love. Our mission is to improve lives through superior nutrition and unmatched personal service. Our team helps ensure that the service we provide, formulas we develop, and literature we publish are client-focused, impactful and accurate. Everything we do must be scientifically and medically sound. We push hard to research new ingredients, seek out the highest quality sources, test new formulas, and operate several research studies and feeding trials at any given time. In 2019 Platinum Performance joined forces with Zoetis, the largest animal Health Company in the world, with a shared vision to to advance the role of nutrition in veterinary medicine and to create the field of scientific wellness on a global scale. We are looking for enthusiastic, passionate people who are excited to move faster, go further and help to redefine what is possible in animal health. Job Description The Regulatory Affairs Specialist provides daily regulatory support to our domestic and international business by keeping current with regulations that affect our business operation with respect to FTC, FDA  DSHEA and FSMA regulations, AAFCO and NASC NGO guidelines, as well as, State registration and licensing and selected international markets registrations. The Regulatory Affairs Specialist will assist R&D and Graphics to develop Nutrition Facts panels for Human Food, Supplement Facts panels for Human Dietary Supplements, AAFCO and/or NASC approved labeling for the animal nutrition market. The RA Specialist will also review and approve labeling and all marketing copy for compliance and make suggestions for edits and corrections. The Regulatory Affairs Specialist will also assist with supply chain compliance by keeping all required supplier documents current with respect to FDA FSMA. Responsibilities Keep current with regulatory environment: FTC, FDA (DSHEA & FSMA), NASC and AAFCO NGOs Work with Product Development and Marketing to develop labeling: Nutrition Facts, Supplement Facts, AAFCO and NASC approved labeling. Review and approve labels and labeling for compliance. Review and approve all marketing and sales copy for compliance.  Make suggestions for corrections to maintain compliance. Keep annual State licensing and registration current. Assist with selected International markets’ registrations. Maintain and keep current all supplier FSMA and DSHEA GMP required documentation. Assist with third party audits and FDA Investigation corrective actions. Keep current with regulatory environment through trade publication, law blogs, and regulatory newsletters and make recommendations for proactive response. Creates and updates SOPs related to daily tasks. Other related projects as assigned by manager. Supports Change Control Program Assist with adverse event and reportable food reporting Qualifications Must be familiar with FDA Regulations: Dietary Supplement Health and Education Act, Food Safety Modernization Act, 21 CFR Part 101 Food Labeling and/or AAFCO and NASC Labeling Guidelines.. Must be proficient in MS Word, Excel, and Outlook. Must be well-organized, detail oriented, and able to work within deadlines as well as under pressure. Strong verbal and written communication skills. Strong organizational and documenting skills. Takes opportunities to develop individual competencies to ensure skills are aligned with evolving roles in the organization. Is open, curious and willing to learn new skills and owns individual development. Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions. Works well with a diverse group. Listens and gets clarification; Participates in meetings; Writes clearly and informatively; Presents numerical data effectively; Able to read and interpret written information. Balances team and individual responsibilities; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Aligns work with strategic goals, Strives to continuously build knowledge and skills. Prioritizes and plans work activities; Uses time efficiently; Develops realistic action plans. Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Completes tasks on time or notifies appropriate person with an alternate plan. Education and/or Experience BS in Food Science, Food Technology, Nutrition, Regulatory Compliance or a related field. Demonstrated knowledge of regulatory compliance in related field. Experience in Regulatory Affairs in human or animal food and/ or human or animal dietary supplements. Master of Science in a related discipline is a plus. Genesis Nutrition Facts Software experience a plus. Trace Gains or Safety Chain supplier management software experience a plus. Additional Information Science and research have always been an integral part of the culture at Platinum Performance. The effects of our formulas on equine health are studied in colleges of veterinary medicine across the country. In addition, scientists in the Platinum Performance Clinical Nutrition Laboratory study cutting-edge ingredients and innovative theories about equine nutrition. It is our belief that revolutionary innovation leads to unmatched results. The wellness products we produce have powered the nutrition regimens of several Olympic gold medalists, professional athletes and that of many horses at the top levels of equine competition.

Keywords: Platinum Performance, Santa Maria , Regulatory Affairs Specialist, Other , Santa Maria, California

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