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Regulatory Manager - ASEA and South Korea

Synthorx

Synthorx

Legal
Seoul, South Korea
Posted on Wednesday, December 27, 2023

Regulatory Manager - ASEA and South Korea

Objective

Seeking a Regulatory Manager to oversee regulatory strategies, product registration, compliance, and risk mitigation for ASEA and South Korea. The role involves collaboration with local and international affiliates, focusing on medicinal products, nutraceuticals, and cosmetics in markets including the Philippines, Vietnam, Hong Kong, South Korea, and Indonesia.

Responsibilities

  • South Korea Focus (70% of role):

    • Develop regulatory strategies for Korean Health Functional Foods (Class II).
    • Manage MFDS applications and ensure compliance with local regulations.
    • Coordinate with distributors or MAH owners for product importation and marketing.
    • Oversee regulatory intelligence and support claims ideation for brand innovation.
  • Business Continuity:

    • Maintain business licenses and compliance with regulatory requirements.
    • Manage product licenses, GMP clearances, importation licenses, and product registrations.
    • Ensure alignment of promotional materials with regulations and internal SOPs.
    • Archive documents and maintain regulatory information in SANOFI systems.
  • ASEA Market Responsibilities (30% of role):

    • Coordinate dossier preparation for cosmetic portfolio.
    • Support SEA Zone portfolio maintenance, including renewals and variations.
    • Track key self-care access initiatives and coordinate SEA Zone projects.

Key Relationships

Collaborate with Regional and Zone Science Hub, Global Regulatory, Medical & Pharmacovigilance, R&D, Manufacturing & Supply, Brand, and Local Commercial teams.

Qualifications

  • Bachelor of Sciences in Regulatory, Pharmaceutical, or related fields.
  • Registration with a local professional association.
  • 1-2 years of experience with Korean Functional Food Regulations, including Class II HFF registration.
  • 3-5 years of experience in regulatory activities, preferably with MFDS experience.
  • Fluency in English and Korean.

Competencies

  • Strategic Thinking and Business Acumen.
  • Strong Judgement and Team Leadership skills.
  • Change Leadership and Personal Leadership.
  • High Drive and Learning Agility.

Cultural Traits

  • Challenge the status quo and prioritize outcomes.
  • Put organizational interests first.
  • Act in the best interest of patients and customers.
  • Proactive and decisive decision-making.

The position requires a dedicated individual with a comprehensive understanding of the consumer healthcare and pharmaceutical industry, capable of influencing and leading within a matrix environment. The ideal candidate will have excellent project management skills and familiarity with Sanofi systems and tools.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.