RAS Associate

1ヶ月前


Tokyo Reckitt
We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands.

Our purpose defines why we exist:
to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.

Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

About The Role


Reporting to Head of Regulatory Affairs and Safety, you are responsible for the regulatory affairs and Safety support and consultancy to internal and external stakeholders in a business-oriented way.

This include liaising with marketing team, R&D, supply, and global/regional regulatory teams.

You will also need to work closely with government agencies, external partners and contractors to ensure regulatory, safety and medical affairs issues are properly managed and resolved.

Your responsibilities

Provide the plans to Regulatory Affairs Director by ensuring that appropriate structures, systems, competencies and values are developed.
Overseeing the submission of registration of new and variation application, strategizing the best expedited route for approval. Maintenance and update of licenses in compliance with local regulatory requirements.
To have overall regulatory activity responsibility for responsible brand and ensure that registration is done in a timely fashion.
Provide regulatory expertise to global product development and regulatory teams.

Proactively leading the development and implementation of strategies to ensure regulatory compliance that results in competitive advantage for the company.

Ensure that the interfaces between Regulatory/Marketing and other departments are managed optimally.
Providing regulatory expertise in area of advertising, label claims, printer materials and importation requirement. Working with R&D and Marketing team to develop and protect key brands' product claims.
Working with R&D, Legal and Marketing team to develop and protect key brands' product claims.
Ensure that all adverse events are dealt with in accordance with company SOPs as well as JP regulation. And support PV report to Global vigilance team

Monitoring and interpreting local regulatory issues/trends/updates that will impact the marketability of company products, ensuring that the business unit is fully aware of the impact.

Ensure effective team communication throughout the Regulatory department through the application of suitable reporting systems and structures and the identification and provision of appropriate training.

Support Regulatory Affairs Director for Industry Association Activity in the categories of OTC drug, Medical Device, Quasi-drug, Cosmetic and Commodity products.

The experience we're looking for

Minimum 2 years of working experience in Regulatory Affairs and in dynamic fast paced environment
Solid experience in the FMCG, Consumer or Pharmaceutical industry
Pharmacist license (Not a must)

Skills/Competencies for success

High energy, sense of urgency and results-oriented with global mindset
Proficiency in Microsoft office application software
Strong interpersonal, communication and presentation skills (both oral and written in English/Japanese)
Outstanding interpersonal skills including developing relationships at all levels in an organization including Reckitt management member and directly influencing business objectives
Committed and strong team player
Ability to successfully prioritize and manage multiple tasks while adhering to specified deadlines
Result driven attitude with a strong sense of accountability

What we offer


With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.

We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally.

We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience.

Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

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