Regulatory Affairs Specialist, Human Health BioSolutions

Posted:
11/5/2024, 4:00:00 PM

Location(s):
Seoul, South Korea

Experience Level(s):
Mid Level ⋅ Senior

Field(s):
Legal & Compliance ⋅ Sales & Account Management

Are you ready for a new beginning?

We need your talent, knowledge and dedication to better our world with biology.

Our purpose points the way

In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.

We’re here to better our world with biology.

In this role you’ll make an impact by:

  • Represents RA and is accountable for the regulatory compliance of businesses in S.Korea.

  • Secure all products can be sold legally including Track regulatory developments and implement new regulatory guidelines and protocols.

  • Develop and coordinate robust regulatory dossiers for new market access, health claims, extended usage for all ingredients as relevant. Maintain existing authorizatons and ensure timely renewals.

  • Manage and engage with external Regulatory authorities and KOLs involved in Regulation development, legislatives harmonization, maintaining relationships to foster a cooperative environment and minimize negative impact on business.

  • Participates in negotiation and interface with regulatory/enforcement authorities.

  • Regulatory advocacy - Represents within specific Industry associations, maintaining positive relationships with KOL’s and drive business positions.

  • Support Sales team and customers on regulatory related queries.

  • Be part of projects including New Product Development, to ensure compliance and successful business expansions. Provides RA insights to the business to ensure innovation strategies take account of regulatory restrictions and opportunities.

  • Ensure that all regulatory activities/registration are logged appropriately in IT systems for reporting.

  • Monitor internal and external legislative changes and share of such information within business.

  • Leads an ongoing focus on improving RA effectiveness and efficiency within self and team.

  • Undertake activities and projects as required by the Department Manager

  • Actively seek to identify and minimize risks to the business, and alerting the Head of Department

  • Undertake general duties and/or projects as required by the business and the Head of Department


To succeed you must hold:

  • Candidates with Masters/Degree within Biotechnology, Genetic engineering, Food Science, Biochemistry, or related disciplines required.

  • Min. 5 years working experience in Regulatory Affairs field directly handling registrations.

  • Min. 2 years of Korean regulatory experiences in food and health functional food

  • Direct experience with functional ingredients Probiotics, HMO, enzymes are an added advantage.

  • Fluent in verbal and written Korean, English

  • A track record of effective internal & external engagement

  • Strong negotiation and influencing skills.

Could our purpose be yours? Then apply today!

At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.
 
Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability, or veteran status.

Want to learn more?
Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com

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