RAS OTC Associate & Drug Safety Officer

Reckitt Benckiser


We are Reckitt

Home to the world’s best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development

In Research and Development, we’re full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals – all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you’ll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

About the role

Reckitt is seeking a dedicated Regulatory Associate, a role that sits at the core of our innovation process, ensuring that our new product developments meet global regulatory requirements with precision. You will act as a catalyst for change, using your detailed knowledge to create comprehensive dossiers crucial for product registrations. At Reckitt, every individual’s contribution is key, and your role will be pivotal in navigating the intricate regulatory landscape to deliver products that enrich lives every day.

Your responsibilities

Deliver registration and compliance activities and projects as per agreed timelines.

Interpret and apply all relevant legislation in Turkey and keep Reckitt local operating company up to date on national regulatory trends, risks and opportunities for the business.

Respond to customer regulatory requests by providing necessary document and information

Provide support for tender RA documentation

Be ready to lead internal investigations into allegations of non-compliance and coordinating the activities necessary to expeditiously resolve local regulatory dispute; assisting in the organization of internal audits and monitor audits performed by 3rd parties.

Preparation and submission of new product registrations (eg: CTD, Food Supplements and Medical Device Registrations) and GMP submissions for medicinal products

Preparation and submission of Type I and Type II variations including safety variations to update SmPC, PIL and labelling in line with Company Core Data Sheets

Ensure that Turkey is coordinated with all internal and external regulations, ensuring that regulation changes are implemented internally and externally.

Ensure that Pharmacovigilance processes are being followed in the local market, whilst liaising with the Global Vigilance Group (GVG) to ensure alignment of pharmacovigilance proceses and complying with local Vigilance SOP.

The experience we’re looking for

Bachelors degree from reputable universities – Bachelor of Science Degree from Faculty of Pharmacy / Masters degree is an additional asset.

2-5 years experience in Regulatory Affairs.

Experience and knowledge in Medicinal products, Food supplements and Medical Devices are an asset.

Excellent command of English.

Ability to combine technical excellence with commercial awareness.

Proficient in multiple computer programs (ie: MS Office, Adobe Acrobat) and others

Ability to manage a variety of cross-organizational projects, working closely with broad range of internal and external teams.

Knowledge and understanding of relevant regulations/guidelines

The skills for success

Commercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business Strategy.

What 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 recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt’s pay for performance philosophy.

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.

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