Regulatory Affairs Manager

Verdesian Life Sciences is in search of an individual to fill the role of Regulatory Affairs Manager in the corporate office in Cary, North Carolina. Individual should already reside in the Raleigh-Durham-Triangle area.

This position entails regulatory oversight of VLS products, projects, and technologies; providing support for animal nutrition products and crop product commercialization internationally through timely product registration and other regulatory compliance initiatives. This position requires close cooperation with cross functional teams and collaboration with the sales, marketing, and business development teams as part of the development and implementation of global business strategy. The position has the responsibility for all animal nutrition, international support to some countries in Asia, and assistance to Regulatory team in South America.

Essential Responsibilities:

• Prepare and/or review regulatory submissions for assigned projects.
• Provide technical review of labels, data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Communicate timely with regulatory agencies, consulting firms, customers, and their regulatory representatives in different countries, frequently using acquired/native language skills or translation tools.
• Prepare or oversee preparation of product SDS according to GHS and local in-market standards (e.g., Associao Brasileira de Normas Tcnicas (ABNT) ABNT 14725-4: 2014).
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Assess, recruit, and management of international regulatory consultants.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Development of internal systems, processes, and tools for efficient global expansion of the core product portfolio.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as labeling or SDS changes, heavy metal analysis documentation, etc.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, brand standards, or compliance issues.
• Prepare or maintain regulatory files as necessary to obtain and sustain product approval.
• Identify, maintain, and manage relationships with external regulatory consultants as needed.
• Actively participate as directed in preparation for the timely completion of regulatory projects, documents, or submissions, both internal and external.
• Prepare additional information or responses as directed or requested by VLS or regulatory agencies.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Attend and actively participate in relevant industry associations on behalf of and in the best interest of VLS.
• Other duties as assigned by supervisor.

Criteria:

• Language Skills: This position requires a self-starting, analytical, detailed, and organized individual with a considerable degree of good judgment, excellent written and oral communication, self-confidence, and the ability to conduct activities without supervision.
• Reasoning Ability: The ability to effectively communicate problems and solutions to team members both orally and in writing, and maintain interpersonal relationships is essential. Must possess ability to multi-task several projects with various deadlines, establishing priorities and meeting deadlines while working in a fast-paced environment.
• Achieves Results: Self-starter, self-disciplined, detailed and organized. Identifies and resolves problem in a timely manner. Prioritizes and plans work activities and uses time efficiently.
• Adaptability & Change Management: Effectively deals with and handles change and uncertainty. Adapts easily and quickly to a changing environment without losing effectiveness.
• Personal Development: Listens well and is aware of personal strengths and weaknesses and takes continuous action to improve personal capabilities.
• Bilingual candidate preferred.
• Computer proficiency (MS Word, Excel, PowerPoint).
• Science background required with advanced degree (PhD preferred) in agriculture, biology, chemistry, or related scientific discipline.

Verdesian Life Sciences is an equal opportunity employer to all, regardless of age, ancestry, color, disability, military or veteran status, national origin, political affiliation, race, religious creed, sex, and sexual orientation.

Equal Opportunity Employer

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