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Regulatory Manager
4 weeks ago
Overview:
Arxada is a pioneering leader with a powerful legacy: Over 120 years of creating specialty chemicals and solutions that potentiate the performance of our customers and their products. Our solutions, our expertise and our support help them to perform better - to be more efficient, more effective and more sustainable. We are passionate about empowering high performance and enabling our employees, partners and customers to realize their full potential.If you like making a difference, we are the company for you Arxada vdo
The Regulatory Manager is part of a team responsible for Arxada’s regulatory affairs in SEA, with a prime focus supporting the IMC (Industrial Microbial Control) Business. Acting as both a leader and a hands-on contributor, deliver business results by obtaining/maintaining regulatory product approvals, responding to regulatory challenges, providing effective customer support and ensuring support for innovation activities.
Provide a high level of expertise and guidance to business leaders on regulatory strategies to optimize the position of products in the market and support a regulatory compliant culture. Obtain relevant product registrations to support sales and marketing; assure company compliance with applicable regulatory requirements; maintain up-to-date knowledge of laws, regulations and policies; provide relevant regulatory documentation e.g SDS and labels; represent Arxada before domestic and international regulatory and legislative agencies to provide relevant information that will influence regulatory decisions.
**Responsibilities**:
- Compiles appropriate dossiers to obtain relevant product registrations and other applicable permits for existing and new products to support the sales and marketing and ensure regulatory compliance of Arxada’s products in SEA.
- Responds to government inquiries during and after product registration in order to continue to comply with changing requirement and represents Arxada before domestic and international regulatory and legislative agencies in order to provide relevant information that will influence regulatory decisions.
- Maintains all product registrations on current basis to ensure compliance with all existing and emerging regulations in SEA.
- Maintains up-to-date knowledge of laws, regulations and policies in SEA that relate to Arxada’s products. Advises appropriate departments within Company of these requirements. Assists Director in establishing procedures to assure compliance with these requirements.
- Provides SDS and product labels according to specific requirements of countries in SEA and provides training on labelling and transport regulations to internal staff.
- Supports and responds to customer’s regulatory questionnaires related to company products as well as other regulatory inquiries from customers in SEA.
- Ensure proper documentation and labeling associated with DOT, IATA, IMO for shipping and handling of all products and ensure compliance with Thailand Customs requirements regarding import and export of company products, customers’ samples as well as raw materials
- Handles other duties and/or special projects assigned by Director of Regulatory Affairs
Qualifications:
- Post graduate qualification and typically 10+ years industrial experience or degree level and typically 12+ years industrial experience with at least 5+ years in regulatory affairs (ideally in antimicrobials).
- People management experience, or a clear aptitude for leading people
- In depth knowledge of the SEA chemicals regulatory framework, particularly the antimicrobials / biocides regulations for materials protection and paints & coatings, and with some knowledge of allied regulations (Cosmetics, Pharmaceutical products, Crop Pesticide Products)
- Strong technical expertise with understanding of chemistry, efficacy, toxicology, ecotoxicology, environmental fate or risk assessment methodologies
- High-level understanding for standards and accurate documentation. Failure to adhere to this competency can lead to dossiers being rejected with consequent financial and time losses
- Demonstrated experience in representing an organization externally and established relationships with appropriate SEA authorities
- Must be detail and deadline oriented, well organized with excellent verbal and written communication
- Strong interpersonal skills and ability to interact with staff on all levels is required
- Excellent networking and communication skills; ability to negotiate both internally and externally - often at higher levels
- Naturally collaborative with a proven ability to partner and influence others at all levels of the organization
- Ability to digest large, complex volumes of data and summarize for dissemination
- Strong analytical, planning, and prioritization skills
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