DuPont Regulatory Affairs Senior Specialist / Manager in Bangkok, Thailand

Regulatory Affairs Senior Specialist / Manager (Job Number: 014646W-01)

Description

Primary Objectives

  • 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

Mainresponsibilities:

  • 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

Qualifications

CANDIDATE PROFILE

Relevant Experience:

  • 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

Accomplishments

  • 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

Schedule: Full-time

Education Level: Bachelor's Degree (±16 years)

Employee Status: Regular

Job Type: Experienced

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