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 and Buscopan, 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 centers. 

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

The Incumbent is responsible for all activities pertaining to regulatory strategy; product registration as per regulatory requirements such as product registration, amendment and promotional materials submission as assigned; business continuity and regulatory risk mitigation and ensuring strict compliance to the local regulations. Defining a clear regulatory registration strategy for NPDs, prepares and follow up regulatory submissions to ensure the timely registration of new products and maintain existing registrations. Liaises with company affiliates both locally and internationally on regulatory issues.

The Regulatory Manager ASEA and South Korea will be responsible to deliver Regulatory operational activity for lead ASEA markets listed below.  Be the key regulatory responsible for South Korea for Medicinal products, Nutraceuticals (Food Supplements, Functional Food, Dietary Supplements, Complementary medicines etc) and Cosmetics:

Philippines

Vietnam

Hong Kong

South Korea

Indonesia

Key Results/Accountabilities

Specific for South Korea (0.7 FTE), with focus on Functional Food Portfolio both Class I and Class II:

Innovations:

Contribute and provide insight for innovation programs leading to innovative regulatory& registration strategies to drive competitive positioning, maximize chances of approval and identify opportunities, regulatory risks and mitigation strategies.

Develop and lead regulatory & registration strategy end to end for Innovative (Class II) Korea Health Functional Foods

Prepare MFDS application according to local regulations/requirements/SOP and ensure filing submission and approval or support MFDS applications when MAH is held by 3rd party but the product is marketed under Opella Korea name

Support distributors or MAH owners in collaboration with brand/project lead to ensure filing submission and securing of importation permits for products in accordance to launch plans MAH is held by 3rd party but the product is marketed under Opella Korea name

Regulatory Intelligence reporting, especially related to Health Functional Food

Support with claims ideation that can support the brand innovation positioning.

Business Continuity:

Manage/Maintenance of business/Company licenses required

Review promotional materials and package materials in alignment with approved/aligned claims while ensuring compliance with local regulations and Sanofi SOP

Ensure that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals and Secure product license by timely updating CMC, CCDS and safety information

Coordinate between local teams and GRA teams to enable the compilation of submission package (including submission document requirement list and currently registered information) and consult with CHC GRA on any regulatory gaps found in regulatory documentation to complete the required submission documents for local affiliate submission.

Maintain product license by submitting on time renewal application and communicate any changes to renewal plans accordingly.

Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.

Management of translations within the SANOFI functional groups for translations were not already available in current Sanofi Archive via SANOFI internal processes.

Archiving of documents in SANOFI’s systems and population of regulatory information after validation into relevant Regulatory Information Management Systems within timelines defined by internal policies and procedures for regulatory systems.

Company registrations

GMP (Good Manufacturing Practice) clearance or Manufacturing Site registrations

Importation Licenses

Product registrations

Applicable for all ASEA markets (0.3 FTE):

Coordinate and contribute to the preparation of the dossiers and responses document to Health Authority question with the stakeholders (Non-Clinical, Clinical Medical, Pharmacovigilance…) for assigned cosmetic portfolio

Support the maintenance of the existing SEA Zone portfolio, managing the maintenance activities such as renewals, variations, discontinuation process via oversight of regulatory maintenance activities by local affiliates

Ensure compliance of regulatory activities for development and marketed products as well as the update of regulatory database and regulatory requirements shared by local affiliates

Consolidation and tracking of key self-care access initiatives by market for ASEA including Switch, e-labelling/Consumer friendly labeling, & OTC ecommerce tracking. 

Oversight of SEA Zone projects and coordinating the communication to key stakeholders and ensure timely execution of planned regulatory activities as well as escalation of any risks and mitigation plans to ASEA Science team

Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy

Close collaboration to support zone Science projects with inputs on regulatory expertise when requested.

Other ad-hoc tasks assigned by ASEA RA Lead

Key working relationships

Regional and Zone Science Hub Head, Global Regulatory, Medical & Pharmacovigilance, 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

Min. 1-2 years of experience with Korean Functional Food Regulations (Imported and Locally produced, need experience with Class II HFF registration).

Total experience of 3-5 years in market regulatory activities and experience with MFDS

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.

Good project management skills and MS office skills (word/power-point/excel).

Knowledge of the Sanofi systems and tools would be an advantage.

Language skills

Fluent spoken and written English and Korean

Cultural traits / P2W Behavior

Push to go beyond the level we have operated until now :
constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment

Put the interest of the organization ahead of own of those of his her team :
consider both short and long term impact of decisions ; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level

Act in the interest of our patients and customers:
actively engage with customers to know their current and future needs; brings an external perspective into decisions

Take action and don’t wait to be told what to do:
take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward

Role model our 4 values: teamwork, integrity, respect, courage

Required Leadership Competencies

Strategic Thinking - ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and develop plans consistent with long-term organizational interests

Business Acumen – Ability to effectively use economic, financial, market, stakeholder, and industry-specific indicators to fully understand and improve business results

Judgement- The ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving, the ability to make effective decisions even when information is ambiguous or incomplete

Team Leadership – Ability to build cohesive, high-performance teams that take accountability and achieve required results

Interpersonal relationships - treating others with courtesy, sensitivity, and respect.

Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation

Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability.  Ability to put patient, stakeholder, and organizational interests above personal interests

Drive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence

Learning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop self

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!