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Regulatory Operations Senior Associate

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 & 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.

The experience we're looking for

  • You bring prior experience in Medical Device regulatory affairs, with a strong track record of successful projects delivered.
  • Experience in maintaining Medical Device dossiers and supporting documentation.
  • You have the knowledge and understanding of global product development and maintenance for Reckitt products, rules, regulations and guidelines current and emerging impacting dossiers/regulatory file maintenance.
  • You have high scientific credentials with a Bachelor of Science (BSc) / Master of Science (MS) degree in a relevant scientific discipline – such as Chemistry, Biological Sciences, Microbiology, Pharmacy, alongside significant applied industry experience. A PhD degree is a benefit but not a requirement.
  • You are a creative, results focused leader, adept at leading organizational transformation, with a strong passion for leading high performance cross-functional teams, built on technical credibility, trust and strong relationships. Bias towards strategic vision, views & articulation with a credible foundation of delivery.
  • Ability to consistently deliver to time, cost and quality standards in a high-pressure environment.

 

About the role

This pivotal Regulatory Manager role offers you the opportunity to champion collaboration across teams, enhancing your leadership abilities. As the bridge between Reckitt and regulatory agencies, your expertise will be key in guiding our innovative products through complex regulatory landscapes to reach consumers safely and efficiently. This role also offers great promotion opportunities, with a Senior Manager position being the next step for strong performance.

Your responsibilities

Responsible for the maintenance and delivery of the Medical Device regulatory dossiers, driving consistency & direction and guaranteeing the appropriate resources and expertise is applied in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings and existing pipeline compliance.

Managing a complex and diverse set of regulatory requirements and landscape overview across multiple markets to enable Medical Device dossier maintenance and compliance post launch.

Ensuring your teams work in collaboration with other X-functional technical functions like Safety, Quality and R&D as well as other RAS areas and local teams to define documentation requirements and data gathering

Responsible for delivering gold standard MDR dossiers for your medical device portfolio ensuring a right first-time dossier approach to ensure best practice is maintained across the portfolio ไhere necessary, support with RI assessments for Medical Devices for post launch activities for all devices within your remit Driving efficiency to deliver on Reckitt business ambitions.

Support the operations manager in preparation for senior forums (where required i.e MDR DA)

Improve technical knowledge and portfolio knowledge within the team by sharing knowledge to junior members of the teamBe the technical expert and poc with Medical Device SME for your medical device portfolio

Ensuring through dynamic resourcing that sections of the dossiers are delivered as per plans and that appropriate and aligned prioritization is implemented. This includes any relevant variations linked with supply and compliance plans for example.

Support the business to refine regulatory processes enabling accuracy and efficiency for speed to market for medical devices

 

 

The skills for success

Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business accumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes, Digital transformation for R&D, Quality and Manufacturing.

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.


Job Segment: Medical Device, Nutrition, Pharmacy, Counseling, Healthcare

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