Regulatory Affairs Manager

Interested in a career that matters?

In this role you will make an impact by:

• Manage submissions of new GMM-derived products in Japan for legal sales and import & trade protection by generating Japan-specific data and preparing high-quality dossiers.
• Represent Novonesis Japan in interactions with government and agency officials (e.g. Ministry of Health, Labour and Welfare; Food Safety Commission; Ministry of Agriculture, Forestry and Fisheries; Ministry of Economy, Technology and Industry) for the product registrations.
• Assess the regulations to give advice to the global colleagues and business functions for our products’ compliance.
• Monitor the regulatory changes, threats and opportunities to evaluate implications towards our new and existing approvals.
• Support the global colleagues and business functions to address our customer inquiries by preparing statements and sometimes directly having meetings with them.
• Work with industry trade associations (Japan Enzyme Association, Japan Food Additive Association etc.) to reflect Novonesis’ inputs in the regulations changes and help to develop an approach that allows the industry to work together on key issues.
• Assess product changes’ impacts and take necessary actions to avoid any business disruptions.
• Prepare or help to prepare the regulation-related documents like product labels, safety data sheets and statements etc.

To succeed you must hold:

• Have B.Sc. at least in biology, biotechnology, food science, toxicology, chemistry, biochemistry or related.
• Prefer to have 5 years working experiences (preferably including one or more of product development/ regulatory/ quality/ food safety disciplines).
• Know the relevant regulations and various guidelines for enzyme product registrations.
• Be very good at communication (oral & written), facilitation and presentation skills, in both Japanese and English.
• Be quick in learning, self-directed, responsible, and able to work both independently and as a team member.
• Have a track record of effective internal & external engagement.
• Have strong negotiation and influencing skills.

Our purpose guides 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. If our purpose resonates with you, we encourage you to apply.

Opportunities for everyone

We are committed to an inclusive recruitment process and equal opportunity for all applicants. Therefore we ask you to apply without a cover letter or photo and instead include a few sentences in your CV explaining your motivation for applying.

We make all employment decisions based on business needs and welcome candidates with a wide range of backgrounds, including ethnicity, religion, gender, sexual orientation, age, disability, or veteran status.

Explore other openings

If this position isn’t the right fit, you may still find other opportunities with us. You’re welcome to explore open roles or create a job agent to stay connected with future opportunities at novonesis.com/Career

Global biosolutions company formed from the merger of Novozymes and Chr. Hansen, specializing in industrial enzymes, microorganisms, and bioscience innovation. Headquartered in Bagsvaerd, Denmark.

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