RAS Associate
We are Reckitt
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
Equality
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Medical Device, Counseling, Nutrition, Healthcare