Regulatory Operations Analyst

Job Description:

Regulatory Operations Analyst – Formulation Assessment (Contract position)

Location: India (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 company 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.

As Regulatory Operations Analyst – Formulation Assessment, you will be responsible for the completion of Regulatory Formulation Assessments for all planned regulatory classifications across all markets.

As a key member of our Global Regulatory Operations within the Regulatory and Safety Team, you will ensure appropriate regulatory checks on formulations are completed and delivered to the operational project teams for inclusions in the relevant parts of the registration files/documents and will ensure regional and market registration in collaboration with local regulatory teams as per plans.

As an SME in Formulation Assessment you will guide Operational and Strategy teams on formulation requirements and will work with them to incorporate labelling and artworks in the corresponding sections of the submission files, and work collaboratively with 3^rd party service providers to ensure RFA/FBA delivery meets the necessary standards.

You will ensure operational excellence of your area of responsibility and will align on priorities and resourcing with the Regulatory Senior Associate Operations RFA/FBA Co-ordinator to whom you will report to.

You will be a critical partner of cross-functional colleagues across the Regulatory Strategy and Operations, Safety, R&D, Procurement, Sustainability, Supply, Quality, and any other department where Formulation Assessment is required. You will ensure that you according to internal and external standards, to ensure our formulations are compliant according to regulations and internal standards.

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 Analyst– Formulation Assessment plays an essential role to achieve and maintain compliance for new products and existing portfolio across the whole product lifecycle, whilst also ensuring we are an effective, well-connected organisation.

You will succeed because ...

• You bring prior experience in Formulation Assessment on multiple regulatory classifications, with a strong track record of successful projects delivered.
• You have the knowledge and understanding of formulation assessment requirements for company products, rules, regulations and guidelines current and emerging impacting formulation assessment.
• 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.
• 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.
• Strategic mindset with demonstrated ability to anticipate future trends accurately and has a broad knowledge and perspective on regulatory implications in the formulation assessment area, and has the ability to adapt them to regulatory operations linked with Formulation assessment activities
• Ability to translate complex regulatory information into a compelling stakeholder friendly language.
• You have strong intellectual curiosity with an appetite for exploring new and previously unchartered territories and an openness to change with ability to think out of the box
• You are passionate about sustainability, have a sustainable growth mindset and will drive solutions around company’s sustainability goals.

Key Responsibilities of the Role will include…

• Responsible for the delivery of the Formulation Assessment (RFA/FBA) content for the relevant registration files/documents, and internal process requirements driving consistency & direction in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings for NPD and existing product changes pipeline.

• Managing a complex and diverse set of regulatory requirements and landscape overview across multiple markets

• Ensuring you work in collaboration with other cross-functional technical functions like Regulatory Strategy and Operations, Safety, R&D, Procurement, Sustainability, Supply, Quality as well as other RAS areas and 3^rd party service providers and local teams to define requirements for RFA/FBA documents.

• Ensuring that projects are delivered as per plans and that appropriate and aligned prioritization is implemented.

• You also will be ensuring:

• Are up to date on Formulation Assessment checks including internal and external regulatory requirements across the company portfolio
• Deliver RFA/FBA content as per project plans using the required process and system.

• Explore potential opportunities and work with relevant departments (Safety, sustainability, Packaging, RAS Strategy) to move to more change resilient formulations.
• Quality checks to ensure compliance with requirements and drive content consistency.