Regulatory Operations Associate Medicines - (12-Month Maternity Cover)

About the Position

We are Reckitt, home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose is to protect, heal, and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose and are looking for a Regulatory Operations Associate for a 12-month maternity cover role in Kingston upon Hull, United Kingdom.

Responsibilities

• Delivery/creation and maintenance of regulatory dossiers/registration and notifications, ensuring accuracy in line with relevant regulations and requirements.
• Showing an understanding of regulatory requirements in the Medicinal classification.
• Working in partnership across RAS teams to develop, communicate, and implement the regulatory strategy in collaboration with cross-functional project teams and aligns on content of the regulatory submission. Preparing and submitting relevant regulatory documentation (e.g., dossiers, notifications).
• Supporting simplification and efficiency projects to deliver on Reckitt business ambitions.
• Engaging in dynamic resourcing process to ensure that regulatory deliverables are supported within the wider Regulatory Operations team.
• Being responsible for supporting input for responses to Regulatory Agency questions.
• Acting as regulatory operations lead on projects with a clear understanding of a broad set of registration/regulatory requirements across multiple markets meeting project objectives and milestones.
• Being responsible for delivering projects following Reckitt’s processes and procedures. Responsible for communicating risks and progress with guidance.
• Inputting into relevant data packages to maintain and deliver best-in-class regulatory packages according to regulatory requirements.
• Creating and collating market-specific documentation, working with relevant regional regulatory and safety partners.
• Providing input into the strategy on dossier/regulatory file.
• Ensuring dossiers/registrations/notifications and regulatory files are maintained.
• Having a good understanding of internal business and regulatory processes.
• Inputting into departmental SOP/work practices as required.
• Supporting audits and audit readiness activities, both internal and external to Reckitt, as requested.
• Developing good relationships with regulatory partners and cross-functional stakeholders to support effective working.
• Maintaining oversight of own resource needs and raising any issues in advance.
• Driving own personal development with the support of line manager.

Requirements

• Having 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.
• Basic knowledge and understanding of: global product development and maintenance for Reckitt products; rules, regulations, and guidelines (current and emerging) that impact dossier/registration and relevant notification maintenance.
• Prior experience in medicines regulatory affairs (or similar legislative area), with a track record of working on global medicines supporting registration/dossiers/notifications and relevant supporting documentation.
• Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registrations.
• Ability to work on multiple projects at any given time and a capability to prioritize and manage your own workload independently (seeking support from line management where required).
• You are agile and demonstrate this by being able to work across different classifications as needed (with supervision and guidance where required).
• You are a creative, results-focused individual with a passion for working collaboratively and with empathy with cross-functional teams, built on technical credibility, trust, and strong relationships.
• Ability to consistently deliver work to time, cost, and quality standards in a high-pressure environment.
• Strive for a high level of accuracy in authoring and/or reviewing documentation for regulatory purposes, with a focus on ensuring the level of registered information is appropriate.
• Able to communicate complex regulatory information and requirements into a compelling stakeholder-friendly language.

Skills for Success

• Regulatory Management
• Product Cycle Management
• 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

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 recognize, appreciate, and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay-for-performance philosophy.

About the Company

We are Reckitt, home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose is to protect, heal, and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose and are looking for a Regulatory Operations Associate for a 12-month maternity cover role in Kingston upon Hull, United Kingdom.