Regulatory Operations Associate, Labelling

Location: India -Gurgaon

You will succeed because ...

• You have high scientific credentials with a degree or equivalent 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.
• Experience of working as part of team is preferred but not essential.
• You have the knowledge and understanding of the regulatory requirements for Reckitt products, rules, regulations and guidelines current and emerging impacting labelling.
• You bring prior experience in labelling projects with a strong track record of successful projects delivered.
• You have an ability to work on multiple projects at any given time and a capability to prioritise 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 with cross functional teams, built on technical credibility, trust and strong relationships.
• You have the ability to consistently deliver work to time and quality standards in a high-pressure environment.
• You strive for a high level of accuracy in authoring and/or reviewing documentation for regulatory purposes.
• Ability to translate complex regulatory information into a compelling stakeholder friendly language.

Key Responsibilities of the Role will include

• Ensuring the labelling and artwork process is correctly adhered to during artwork development and revisions to maintain compliance and drive consistency.
• The creation, review, approval, update and maintenance of all documentation and items related to labelling and artwork generation within Reckitt.
• Ensuring the label content is correct, adheres to the latest regulations and aligns with the Regulatory dossiers and technical files. This includes (but not limited to): claims we make in our labels have the adequate substantiation and the symbols meet the latest regulatory standards.
• Delivery of the labelling content for inclusion in the relevant sections of the Regulatory dossiers and technical files in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings for new products and the existing pipeline.
• Ensuring the accuracy, consistency, quality and compliance of labelling data within the key business systems such as Brandworks, Nexus, CARA and PLM (TDS and Optiva) is maintained. Any errors or non-compliance issues to be identified are flagged accordingly and resolved in a timely manner.
• Working in collaboration with other X-functional technical teams like Safety, Medical, R&D, Marketing, Packaging and Quality as well across Global and Local Regulatory to define requirements for labelling.
• Ensuring that projects are delivered as per plans and that appropriate and aligned prioritisation is implemented. Notify line manager and project teams of any issues or potential delays to projects accordingly and in a timely manner.
• Support other members of the labelling team with their knowledge and understanding of the labelling requirements as required. Additionally, demonstrate you are a team player by sharing the workload, if required, to enable the delivery of the labelling content for projects on time.
• Demonstrating an understanding of regulatory requirements related to labelling and for efficient execution across classifications.
• Ensuring you are up to date with the latest regulations and standards plus emerging requirements and how they will impact Reckitt labelling requirements.
• Creation and/or completion of any document type requested for the successful management and/or organisation of the labelling team to support with the delivery or planning of tasks and activities. Examples include completion of trackers, recording of minutes and actions from meetings, supporting other team initiatives.

Key Measures of Success in the Role will include

• Ability to deliver accurate and compliant labelling content on time to the project team. Any delays incurred due to the labelling team must be communicated to the relevant stakeholders in a timely manner with a clear justification for why.
• Target 100% of labelling content to be delivered correct first time.
• Target 0% planned changes from the artwork process and other internal procedures.
• Target 0% deviations as a result of labelling team errors due to not correctly following the artwork process and other internal procedures.
• Target 0% corrections (at time of review and approval) on dossier and technical file sections where input has been required by the labelling team.
• Notifying the line manager of the labelling team when compliance issues have been identified with a plan on how to successfully resolve e.g. corrective and preventative actions.
• Demonstration of the Leadership Behaviours via positive feedback from stakeholders within regulatory and across the cross-functional team. Examples include asking the right questions to support successful delivery of labelling content, providing new ideas to ensure the success of the labelling team and attitude towards colleagues.