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.
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 responsibilitiesProvide 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 forMinimum 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.
Show more Show less-
RAS Associate
1日前
Tokyo ReckittWe are Reckitt Home to the world's best loved and trusted hygiene health and nutrition brands. · Join us in our fight to make access to the highest quality hygiene wellness and nourishment a right not a privilege. · ...
-
Japan BeiGene ￥2,000,000 - ￥2,800,000 per yearWe are looking for a Senior Manager or Associate Director to lead our Lifecycle Regulatory Affairs team in Japan. · ...
-
Tokyo Organon Full time￥150,000 - ￥250,000 per yearWe are seeking an Associate Director to join our Japan Regulatory Affairs team. The successful candidate will be responsible for developing new drug regulatory strategy for Japan and collaborating with commercial and local stakeholders to align regional regulatory strategy with c ...
-
Tokyo Hoya Vision Care ￥800,000 - ￥1,200,000 per yearThe Cluster Senior Regulatory Affairs Manager will develop and maintain regulatory strategies for marketing authorization applications in cluster countries, ensuring compliance with global and regional requirements. The role involves monitoring operational progression of pre-mark ...
-
Tokyo Boston Scientific+Job title: · Sr Sr Specialist RA · +Ensures rapid approvals for respective product lines by planning all registrations. · Interacts with regulatory agency personnel to expedite approval of pending registration.Provides management team with regular updates on product registration ...
-
Tokyo Servier ￥120,000 - ￥180,000 per yearFor studies, ensure the set up and the progress of the clinical studies under responsibility, in accordance with local regulations, Good Clinical Practices, internal procedures, technical protocols. · Support the Japanese development strategy to the Core Team/Asset Team · Conduct ...
-
Tokyo Amgen Full time￥10,000,000 - ￥20,000,000 per yearThe Japan Regulatory Strategy Group Sr Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen' ...
-
Tokyo Gilead Sciences ￥2,500,000 - ￥4,500,000 per yearWe're seeking a Sr Manager, Marketing Operations Omni-Channel Strategy Manager to join our team at Gilead. As a key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. · This individu ...
-
薬事部 スタッフ
3週間前
Chūō Johnson & Johnson Innovative Medicine Full time￥1,500,000 - ￥4,000,000 per year+The RA staff plans regulatory affairs activities for new and existing products. · +Interpreting regulations · Leading cross‑functional implementation of compliance measures · Communicating with health authorities · +- More than 5 years of experience in regulatory affairs · - Co ...
-
薬事部 スタッフ
3週間前
東京都 中央区, Johnson & Johnson ￥1,000,000 - ￥1,200,000 per yearThe Regulatory Affairs staff at Johnson & Johnson plans coordinates executes Regulatory Affairs activities new existing products. · Actively participate strategic discussions cross functional team members. · Plan regulatory activities assigned projects. · ...
-
薬事部 スタッフ
2日前
Chuo-ku, Tokyo Johnson & Johnson MedTechThe RA staff in this role plans, coordinates, and executes Regulatory Affairs activities for both new and existing products. · ...
-
Chiyoda myGwork - LGBTQ+ Business Community ￥1,300,000 - ￥1,800,000 per yearThis job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT) · Princ ...
-
Chiyoda Johnson & Johnson Innovative Medicine ￥1,200,000 - ￥2,500,000 per yearThe R&D Specialist/Manager is responsible for leading Japanese regulatory strategy and target labeling in J-CDT, sharing information with the Global Regulatory Team (GRT), and participating in GRT meetings to provide Japanese input. ...
-
Chiyoda Johnson & Johnson Innovative Medicine Full time$120,000 - $180,000 per yearLead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT). Prepare Common Technical Document (CTD) for Japan. Provide input on study design, conduct, and need for any additional studies for Japan. · ...
-
Animal Health
4週間前
Tokyo, Tokyo MSD $80,000 - $120,000 per yearThe Associate Director of the Regulatory Affairs (RA) is responsible for managing regulatory affairs activities including pharmacovigilance work at RA department at PDRA division Animal Health in Japan. · Primary Activities · Support PDRA director to optimize/maximize PDRA's acti ...
-
Manager, GRA CMC
2日前
Tokyo, Tokyo SanofiThe incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan. · ...
-
Tokyo, Tokyo Amgen ￥1,500,000 - ￥2,500,000 per yearThe Japan Regulatory Strategy Group Sr Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen' ...
-
Manager, GRA CMC
20時間前
Tokyo Sanofi ￥8,000,000 - ￥12,000,000 per year+ Develops innovative Japan regulatory CMC strategies and risk assessments for development projects. · + Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. · Key ResponsibilitiesDe ...
-
Tokyo Talisman CorporationThe company is a leading firm for rare diseases. · Quality professional with strong subject knowledge, both in depth and breadth. · ...
-
Tokyo, Tokyo SanofiThe Japan Project Head (JPH) would be responsible for overall Japan development strategy for vaccine project in alignment with Global project strategy as well as Sanofi R&D strategy business objectives. · ...
-
Tokyo Ferring Pharmaceuticals ￥4,500,000 - ￥9,000,000 per year+This is a key middle management role with both local and global impact at Ferring Pharmaceuticals. · +Influence both local and global quality decisions and business contributions through quality operations. · Work closely with SCM, RA,CMC and global teams · ,1} ...
