DuPont Regulatory Affairs Senior Specialist / Manager in Bangkok, Thailand
Regulatory Affairs Senior Specialist / Manager (Job Number: 014646W-01)
Timely and efficient internal andexternal authorisation to manufacture and market existing and new industrial enzymeproducts
Build and maintain knowledge of relatedproduct stewardship and national product registration processes andrequirements to support business strategy
Coordinate informationcollection on customer end uses in support of product stewardship andregulatory approvals/ clearance for enzymes and other biotechnology productsused in animal nutrition, biorefineries biomaterials, and food applications inThailand and neighbouring countries.
Prepare high qualitydossiers in accordance with country specific requirements to achieve regulatoryapprovals / clearance for portfolio of IB products.
Act as afocal point for food safety and biotechnology regulatory information relevantto Industrial Biosciences’ products in Thailand.
Representsdepartment in assigned projects or product development teams
Partner with thedifferent functions including R&D, Sales and Supply Chain to communicateregulatory & product stewardship requirements/ information to supportbusiness needs
Interactwith regulatory agencies and/or trade associations within defined area(s) ofresponsibility/expertise
Monitor regulatory andsocietal changes representing threats and opportunities, and evaluate/advise onimplications for compliance and acceptance of new and existing products
Manage and implement regionalchanges resulting from global regulatory strategy, such as changes in productsand processes
Manage and resolveregulatory and stewardship issues raised by external and internal stakeholders tosecure new approvals and maintain existing portfolio
Ensure compliancewith applicable external regulations and internal standards, including audits
Maintaindocumentation and regulatory databases
BS/MS in lifesciences or related field, and 3-7 years’ experience in biotechnology,regulatory affairs or related areas.
Good knowledge ofscientific principles and practices related to registration of enzyme or otherbiotechnology products, which may include molecularbiology, toxicology and applicable general scientific methods in R&D, Qualityor Environmental Sciences
Experience inpreparing clear, accurate submissions/dossiers or similar documents applicableto Product Stewardship and Regulatory
Successfullyrepresented the company in interactions with regulatory agencies, customersand/or trade associations in food, biotechnology, or animal nutrition
Successfullyprepared dossiers and gained regulatory clearance for product(s)
Successfullyimplemented regulatory and/or product stewardship policy(ies)
Noticeableinfluence on the success of future products and processes
Primary Location: APAC-Thailand-Bangkok-Bangkok
Organization: Industrial Biosciences
Education Level: Bachelor's Degree (±16 years)
Employee Status: Regular
Job Type: Experienced
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