Global Regulatory Senior Associate

2 weeks ago

Shanghai, Shanghai, China Reckitt Full time

Global Regulatory Senior Associate

City: Shanghai

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

Embark on a strategic journey with Reckitt as an Regulatory Senior Associate, where you will be instrumental in the global launch of our innovative products. Your expertise will help navigate the complex regulatory landscape and create strategies that ensure our diverse range of products, from medical devices to cosmetics, meet the highest standards and reach markets successfully. This role blends scientific acumen with a passion for quality and efficiency. If you're ready to take on a challenge that impacts the health and wellness of people worldwide, we want to hear from you.

Your responsibilities

-Good working knowledge of the China regulatory landscape for medical devices is essential, experience in working with regulatory authorities across Asia, the EU and the US would be advantageous.

-Support interpretation of new requirements or regulation changes and communicate to stakeholders.

-Support and deliver training to business partners, materials that optimally prepare the business for the present and future regulatory environment.

-Develop, communicate, and implement the regulatory strategy in collaboration with cross-functional project team and aligns on content of the regulatory submission. Prepare and submit registration dossiers whilst ensuring global activities are appropriately impact assessed for world-wide implications.

-Supports team to achieve targets and understanding of resource requirements. Helps set clear priorities, reviews project progress and is able to develop a gap analysis and implement resolutions.

-Strong understanding of internal business and regulatory processes.

-Responsible for authoring and reviewing departmental SOP/work practices.

-Seek opportunities to drive simplification.

-Support audits, both internal and external to Reckitt, with a good level of knowledge in Regulatory guidelines and internal procedures. Support regulatory audit readiness.

-Proactively identify and promote relationships with regulatory partners and cross functional stakeholders to support effective working. Highlight the win-win nature of collaboration.

The experience we're looking for

-Educated to degree level in a scientific field or equivalent experience.

-A typical Senior Associate will have approximately 5 years or more experience in Regulatory or the consumer Health Industry.

-Ability to interpret, apply, and implement regulations and guidance. Share knowledge and experience with peers and cross-functional team.

-Understanding and interpretation of global product development practice, rules, regulations, and guidelines.

-Familiarity with factors likely to influence the regulatory environment, both regionally and globally, including new and emerging guidelines relevant to dossier deliveries.

-Experience in a regulatory environment which may cover different classifications, procedures, and registrations. It should also include experience in preparing and submitting dossiers and variations.

-Relevant regulatory experience and knowledge in dossier / technical file creation and global registrations.

-Experience in working with partners to build regulatory strategies.

-Good communication skills and the ability to educate on regulatory situations to non-regulators.

-Should be comfortable negotiating, dealing with ambiguity and conflict management.

-Demonstrates strategic agility, problem solving, delegation and drive for results.

-Ability to consistently deliver to time, cost, and quality standards in a high-pressure environment.

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, Counseling, Healthcare

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