ASEA and Korea Regulatory Manager

• Position: Regulatory Affairs - Country / Platform / Zone
• Location: South Korea

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.  

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. 

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax, Buscopan, Mucopect and Cenovis, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.  

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centres. 

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. 

Join us on our mission. Health. In your hands.

Job Purpose

As regulatory affairs manager, you will play a pivotal role in managing regulatory strategies and ensuring compliance for our diverse portfolio of consumer health products in the Korean market. This position will be an individual contributor role and responsible for the navigation of Korean regulatory frameworks specifically for Pharmaceuticals including Prescriptions and Over the counter medicines and Health Functional Food containing both class 1 and class 2 ingredients and collaborate with cross functional stakeholders to ensure the continued access of our consumers to our loved brands and to bring innovation for our brands.

Key Results/Accountabilities

Korea specific activities

• Develop and implement regulatory strategies for Opella Korea products
• Manage regulatory submissions, variations and renewals for Pharmaceutical Drugs (Prescription and OTC) and Health Functional Food, including company importation licenses
• Ensure compliance with Korean regulatory authorities, specifically MFDS requirement
• Prepare and review product labelling, packaging and promotional materials to effectively execute product claims while ensuring regulatory compliance
• Effective collaboration with cross functional teams, including R&D, brand marketing, supply chain, quality and commercial, contributing to produce development and innovation launches to support brand strategy
• Stay abreast of changes in relevant Korean regulations and provide strategic inputs on their impact on business
• Provide regulatory guidance to internal stakeholders to support business decisions
• Manage and track regulatory projects, ensuring effective and timely communication with key stakeholders on committed deliverables to ensure timely launch of innovations as well as business maintenance
• Ensure accurate and timely update of regulatory responsible information into Company GxP systems within timelines defined by company SOP.

For non-Korea related activities:

• Support the ASEA RA Lead Markets for ASEA related projects
• Ad-hoc tasks assigned by ASEA RA Lead

Key working relationships

ASEA Zone Science Hub Head, Global Regulatory, Medical & Pharmacovigilance, ASEA R&D teams, Manufacturing & Supply, Brand team, Local Commercial team, Other key stakeholders

Skills, Experience & Knowledge Requirements

Education

• Bachelor of Sciences (Regulatory, Pharmaceutical or Pharmacy related fields preferred)
• Registered with local Professional association holding a valid licence.

Required knowledge and/or experience

• Experience and knowledge in either health functional food or pharmaceuticals drugs
• 1-3 years’ experience with MFDS for local submissions and approvals
• Experience with other Asia pacific markets would be an advantage.
• Excellent understanding of the consumer healthcare and pharmaceutical industry, drug development environment, and R&D processes and objectives
• Demonstrated success in partnering and influencing across a matrix environment with exceptional executive communication skills.
• Proven ability to mange multiple projects and meet deadlines in a fast-paced consumer healthcare environment
• Good project management skills and IT skills (word/power-point/excel/AI applications).
• Strong analytical skills and good attention to detail

Language skills

• Excellence communication in both Korean and English

Cultural traits

• Courageous – be bold and unafraid to challenge status quo
• All in together – collaborate seamlessly across functions, embracing a team first mentality to achieve common goals
• Outcome Obsessed – focus on results, ensuring alignment of business objectives and contribution to team success
• Radically Simple – strive for clarity and efficiency in processes and communication, both internally and externally