Regulatory Affairs Specialist

4 days ago

Kuala Lumpur, Malaysia Novonesis Full time

**Location**: Malaysia : Kuala Lumpur
**Country**: Malaysia**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.**What would your role look like?**
- Represents RA and is accountable for the regulatory compliance of businesses in S.Korea and Japan.
- 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

**Who are we looking for?**
- 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

[Not translated in selected language]

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?**Not the right fit for you?**
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