Associate Manager, Regulatory Affairs, Korea, HNC, APAC

DSM
Seoul
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 5+ yearsEducation: bachelorsSkills: ["Organizational skills","Analytical skills","Project management","Communication skills"]

Develop and execute regulatory strategies for Health, Nutrition & Care (HNC) products across assigned markets, supporting product lifecycle management and expansion into new markets. Serve as the primary Regulatory Affairs contact for cross-functional teams, ensuring compliance through interpretation of regulations and management of submissions. Lead regulatory assessments for classification, claims substantiation, labeling, registrations, and notifications, manage regulatory risks and advocacy, and deliver regulatory milestones end-to-end.

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FursaFursa
DSM
DSM
1 month ago

Associate Manager, Regulatory Affairs, Korea, HNC, APAC

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Last checked: 12 hours agoStatus: Live

Job Summary

Develop and execute regulatory strategies for Health, Nutrition & Care (HNC) products across assigned markets, supporting product lifecycle management and expansion into new markets. Serve as the primary Regulatory Affairs contact for cross-functional teams, ensuring compliance through interpretation of regulations and management of submissions. Lead regulatory assessments for classification, claims substantiation, labeling, registrations, and notifications, manage regulatory risks and advocacy, and deliver regulatory milestones end-to-end.
Location: Seoul
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

  • •Develop and execute regulatory strategies to support product lifecycle management, market expansion, and commercialization of HNC solutions.
  • •Partner with cross-functional stakeholders (Innovation, Marketing, Sales, Quality, Operations, Product Management) to provide regulatory guidance throughout development and commercialization.
  • •Ensure regulatory compliance by interpreting regulations, assessing requirements, and managing regulatory activities and submissions.
  • •Lead regulatory assessments and provide strategic advice on product classification, claims substantiation, labeling, registrations, notifications, and market access requirements.
  • •Drive regulatory advocacy, identify and mitigate regulatory risks, and manage regulatory projects end-to-end to deliver milestones.

Key Requirements

  • •Bachelor’s degree in Science in Pharmacy, Life Sciences, Food Science, Food Technology, or related field; advanced degree preferred.
  • •At least 5 years of experience in regulatory affairs within the pharmaceutical or food industry.
  • •Proven track record of successful regulatory submissions and approvals.
  • •Strong understanding of country guidelines and regulatory requirements.
  • •Excellent organizational, analytical, and project management skills, with Korean native proficiency and business-level English for stakeholder work.
Experience:5+ yearsPharmaceutical industryFood industry
Education:Bachelor's in Science; Pharmacy, Life Sciences, Food Science, Food Technology (or related field)
Skills:Organizational skillsAnalytical skillsProject managementCommunication skills
Languages:KoreanEnglish

Company Brief

DSM
DSM-Firmenich is a global leader in food ingredients, nutrition, fragrances and beauty solutions, formed by the merger of DSM and Firmenich to provide sustainable, science-driven products and services across food, health and personal care industries.
Industry: Chemical Manufacturing
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Established Company
Headquarters: Geneva, Switzerland
Founded: 2023
WebsiteLinkedIn