What are the responsibilities and job description for the Regulatory Affairs Specialist position at AMOREPACIFIC?
Job Summary
AMOREPACIFIC US Inc. is seeking a Regulatory Affairs Specialist to join the Americas R&I Center. This role is responsible for ensuring business compliance with North American regulatory requirements by reviewing ingredients, formulations, clinical and in vitro testing, as well as packaging and marketing assets from a regulatory perspective. The position plays a critical role in maintaining compliance across all product-related activities in the US and Canada.The role requires close collaboration with cross-functional teams, including US Marketing, Legal, and HQ R&I and Marketing, to ensure alignment on regulatory requirements and support business objectives. In addition, the position involves working closely with the Global Regulatory Lab at HQ R&I to monitor legislative changes and contribute to the continuous update of internal policies for global regulatory compliance.This role is essential in supporting both local and global regulatory strategies, ensuring that all products and marketing materials meet applicable regulations while enabling the business to operate efficiently and compliantly in the North American market.
Principal Accountabilities
AMOREPACIFIC US Inc. is seeking a Regulatory Affairs Specialist to join the Americas R&I Center. This role is responsible for ensuring business compliance with North American regulatory requirements by reviewing ingredients, formulations, clinical and in vitro testing, as well as packaging and marketing assets from a regulatory perspective. The position plays a critical role in maintaining compliance across all product-related activities in the US and Canada.The role requires close collaboration with cross-functional teams, including US Marketing, Legal, and HQ R&I and Marketing, to ensure alignment on regulatory requirements and support business objectives. In addition, the position involves working closely with the Global Regulatory Lab at HQ R&I to monitor legislative changes and contribute to the continuous update of internal policies for global regulatory compliance.This role is essential in supporting both local and global regulatory strategies, ensuring that all products and marketing materials meet applicable regulations while enabling the business to operate efficiently and compliantly in the North American market.
Principal Accountabilities
- Review and approve product labeling, packaging, and advertising materials to ensure compliance with current regulatory requirements.
- Monitor and assess regulatory and legislative changes in the North American region (federal and state), and propose appropriate internal action plans.
- Manage product registrations, notifications, and renewals, ensuring timely and accurate submission and maintenance.
- Support regulatory compliance related to import/export activities and customs clearance.
- Monitor post-market surveillance and vigilance activities, including handling customer complaints related to OTC and cosmetic products, and support risk assessment and mitigation in accordance with internal SOPs.
- Collaborate effectively with cross-functional teams and serve as a key communication channel between stakeholders and reporting lines.
- Track competitor regulatory activities and industry trends, update internal guidelines, and propose compliant alternatives to support business needs.
- Participate in regulatory meetings, industry conferences, and relevant forums; summarize key insights and drive necessary internal actions.
- Monitor trade barrier developments, NGO activities, and broader regulatory and socioeconomic trends that may impact the business.
- Achieve or exceed established KPIs (Key Performance Indicators).
- Bachelor’s degree in chemistry, biology, pharmacy, food science, or a related science/engineering field.
- Minimum 2–4 years of relevant experience in regulatory affairs and/or product development within the beauty, cosmetics, food, or pharmaceutical industry preferred.
- Fluency in English is required; Korean language proficiency is preferred.
- Willingness and ability to travel domestically and internationally as needed.
- Strong written and verbal communication skills.
- Strong research, data gathering, and summarization skills (e.g., literature or web-based research).
- Analytical thinking and problem-solving skills, with the ability to develop practical and compliant solutions.
- Ability to stay up to date with regulatory requirements, industry trends, and best practices.
- Ability to work effectively in a fast-paced and dynamic environment.
- Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
- Strong business acumen and commercial awareness.
- Ability to build relationships and collaborate effectively across functions.
- Alignment with AMOREPACIFIC’s ABC Spirit and core values.
- Proactive, self-motivated, and results-driven with a high level of ownership.
- High level of integrity, professionalism, and accountability.
- Detail-oriented, resourceful, and able to manage multiple priorities effectively.
- Strong sense of urgency with the ability to meet deadlines and adapt to changing priorities.
- Resilient and able to work under pressure in a fast-paced environment.
- Ability to work both independently and collaboratively as part of a team.
- Hands-on approach with a willingness to take initiative and drive outcomes.