RAS OTC Associate & Drug Safety Officer
We are Reckitt
Research & Development
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
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
What we offer
Equality
Job Segment:
Medical Device, Pharmacovigilance, Counseling, Nutrition, Pharmacy, Healthcare