Regulatory Operations Specialist Medicines - FTC

We are Reckitt

​Research & Development​

About the role

The Regulatory Operations Specialist plays an essential role in a team that works across the medicinal regulations to deliver high quality variation packages efficiently. You will ensure appropriate levels of detail within the files for internal purposes and ongoing maintenance activities throughout the full product lifecycle. You will ensure business agility in manufacture and supply activities and will strive to maintain an excellent level of compliance for our products globally. 

You will ensure that all regulatory dossier activities are completed according to the best process, in a consistent approach across projects. You will work alongside a wide range of cross functional stakeholders including the RAS Global function, Medical, R&D, Supply, Quality and Marketing. 

Your responsibilities

• Supporting a complex and diverse set of regulatory requirements and landscape overview across multiple markets to enable dossier maintenance and compliance post launch. 
• Responsible for delivery of high quality submissions to agreed operations time frames and collaborating across partner functions to ensure timely delivery of all information required.
• Supporting non dossier maintenance activities e.g. GMP documentation support for any/all of the Reckitt medicinal manufacturing sites globally.
• Ensuring all activities are performed in line with the operating model and internal best practice including the compliant use of all systems to ensure audit readiness at all times.

Key Challenges:

• Working in a fast paced FMCG environment to ensure that a product remains compliant during its lifecycle post approval, with no loss of supply due to a regulatory reason.
• Keeping on top of the ever changing regulatory environment and ensure that all relevant information is applied to all necessary product and dossier updates.
• Meeting business / project deadlines in a pressurised environment.
• Building relationships across Regulatory, the wider R&D community, and supply functions within Reckitt. 

The experience we're looking for

You will succeed because ... 

• You bring prior experience in regulatory affairs and knowledge in dossier creation and global registrations.  
• Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registrations
• Experience in preparing and submitting dossiers for medicinal registrations and supporting documentation.  
• A proven ability to work on multiple projects at any given time and a capability to prioritise and manage your own workload independently and as part of the wider team.
• You have basic knowledge and understanding of global product development and maintenance for Reckitt products, rules, regulations and guidelines current and emerging impacting dossiers maintenance.
• You have 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.
• You are a creative, results focused individual with a strong passion for working collaboratively with cross functional teams, built on technical credibility, trust and strong relationships.  
• Ability to consistently deliver to time, cost and quality standards in a high-pressure environment.
• You strive for a high level of accuracy in authoring documentation, with a focus on ensuring the level of registered information is appropriate in the dossiers.  
• Ability to communicate complex regulatory information and requirements into a compelling stakeholder friendly language. 

The skills for success

Regulatory, Task Execution Under Pressure, Business Acumen, Commercial Awareness, 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.

What we offer

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.