Regulatory Operations Specialist
Reckitt
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- Regulatory Operations Specialist
- City: Chachoengsao
- 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.
- Research and Development
In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
As Regulatory Operations Associate, you will be responsible for supporting regulatory activities for the compilation, preparation, review and submission of regulatory documents to Notified Bodies and where applicable Health Authorities to support the launch of new innovations, roll outs of new and existing products, maintain local licenses and maintain regulatory compliance though out product life cycle.
- Your responsibilities
- Responsible for the creation, delivery and maintenance of medical device regulatory dossiers in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings and existing pipeline compliance.
- Work in partnership across RAS teams to deliver regulatory operations activities with cross functional project team and aligns on content of the regulatory submission. Prepare and support submission of registration dossiers whilst ensuring global activities are appropriately assessed for world-wide implications.
- Ensuring you work in partnership with other X-functional technical functions like Safety, Quality, Medical, Marketing, Supply, Packaging and R&D as well as other RAS areas and local teams to define requirements for submissions in efficient and timely manner.
- Be responsible for coordinating responses to questions received from regulatory authorities.
- Deliver activities with a clear understanding of a broad set of registration/regulatory requirements across multiple markets meeting project objectives and milestones.
- Flag any risks or concerns with line manager to prevent any foreseeable risks.
- Accountable of delivering project results following Reckitt’s processes and procedures. Responsible of communicate risks and progress with guidance.
- Understanding of internal business and regulatory processes.
- Seek opportunities to drive simplification and opportunities.
- Support audits and audit readiness, both internal and external to Reckitt, with a good level of knowledge in Regulatory guidelines and internal procedures.
- Proactively identify and promote relationships with regulatory partners and cross functional stakeholders to support effective working. Highlight the win-win nature of collaboration.
- Maintain oversight of own resource needs and raise any issues in advance.
- Drive own personal development with the support of line manager, as well as supporting development of individuals within team.
- Ensuring that projects are delivered as per plans and that appropriate and aligned prioritization is implemented.
- Ensuring regulatory information on various systems and databases are kept up to date
- The experience we're looking for
- - 0-3 years of experience within the regulatory field, ideally supported by a BSc or MSc in a scientific discipline such as chemistry, biomedicine, or pharmacology.
- - Ability to work under pressure while ensuring task execution and adherence to deadlines.
- - Developing business acumen and commercial awareness, with a view to understanding product lifecycle management.
- - Capacity for insight into consumer needs and expectations.
- - Eagerness to collaborate, build partnerships, and continuously innovate.
The skills for success
Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.
- 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 re