Regulatory Operations Publishing Hub Specialist

Location: Gurgaon

Regulatory and Safety Affairs is a critical function within R&D: a key partner in developing the right portfolio strategy for brilliant innovation, activation in our markets and secure the products during all product life cycle.

We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to Reckitt to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve. Data, and data accuracy Is a foundational element of regulatory processes and directly influences the effectiveness of the organisation and its ability to deliver compliant and competitively positioned products.

As Regulatory Operations Specialist Publishing you will be responsible for the compilation and publishing of all regulatory data packages required across the product lifecycle stages, initially focused on the global medicinal portfolio and will reach further into other classifications once established.

In your role you will be responsible for the quality, accuracy, and timely population of data within the key business systems which support publishing activities. You will become a subject matter expert in the use of these systems and the business processes which support them. You will partner with the wider Operations Regulatory team to understand and meet its publishing needs.

You will lead reviews with the wider Operations Regulatory team to feed back on publishing activities ensuring we deliver to key stakeholders in areas such as accuracy, timeliness etc. Where required, and in conjunction with the wider Operations Regulatory teams, you will use continuous improvement methodology to improve internal business processes and systems which support Publishing activities.

You are proficient in the field of publishing, and you will use your experience to execute your role effectively and to a high level of compliance with the applicable standards and external industry expectations.

You will play an important role because.

We’re proud of our organisation and continually strive to be the best that we can be.

The Regulatory Operations - Publishing plays an essential role in leading a team that deliver critical services to the broader Regulatory Operations function.

You will succeed because ...

• You bring prior experience in the field of regulatory publishing, with a strong track record of successful delivery.
• You are skilled in the identification of key stakeholders and have a strong capability for building mutually beneficial partnerships based on openness and transparency.
• Have good communication skills and capability to keep key stakeholders consistently informed and updated across a broad range of subjects and processes in real time.
• You have broad knowledge of regulatory processes, with particular emphasis on medicines, but experience in other classifications is considered beneficial.
• You have knowledge of the medicinal dossier structure and regulations / guidance for global markets, medicinal publishing requirements, document repositories, common validation publishing challenges, and management of sequences and submission tracking throughout the product lifecycle.
• You will have knowledge of the worldwide publishing standards including, Nees, ACTD, eCTD, US, Swiss and South Africa
• Have knowledge or experience in the use of publishing tools / solutions such as Lorenz Documbridge etc.
• Ability to consistently deliver to time, cost and quality standards in a high-pressure environment.
• Demonstrates courage and empathy and work collaborative cross-functional, through change by adopting a growth and compliance mindset and inclusive/expansive leadership.

Key Responsibilities of the Role will include

• Responsible for delivering all publishing activities on time and to a high-quality standard. All publishing activities includes: collating all required documents, compilation, validation of all modules and publishing of the dossier/ensuring the submission package is ready for publishing.
• Fostering productive relationships with those stakeholders critical to your role and maintaining high level of communication to ensure buy in and engagement.
• You will apply the principles of continuous improvement to consistently and critically review internal processes to identify and deliver increased efficiency, compliance or other business benefit.
• Training your publishing team to a high level of knowledge and competency in publishing processes.
• Deliver regular updates on work deliveries, transparency in the execution plans and dates, project management alongside reg ops teams.