Regulatory Affairs Assistant Specialist / Specialist iş ilanı açıklaması
Genel Nitelikler
VSY& VSY Biotechnology focus on ophthalmalogy specific products with a wide range of products, VSY portfolio includes IOL technologies to treat cataracts and refractive errors like presbyopia, astigmatism and ocular problems and also medical devices,Rx products.
VSY is a progressive and innovative company that focuses on customer satisfaction by creating superior state of the art ophthalmology products designed and manufactured to greatly enhance and improve vision for ophthalmologists and patients around the globe.
Starting from foundation to today, quality and safety standards are the source of our success. We are serving over 50 countries around the globe from our headquarter with a professional marketing and distribution approach. With our know-how in ophthalmology and biotechnology,we are renewing and expanding the range of products every day for valuable eyecare professionals, satisfied customers and a healthy future.
We are looking for Regulatory Affairs Assistant Specialist/Specialist to be considered for ophtahalmology portfolio. Responsible Regulatory Affairs Assistant Specialist/Specialist will work at the headquarter where is located in Tuzla/İstanbul.
The candidate should have the qualifications stated below;
Minimum 2 years of experience in Regulatory Affairs; preferably in pharmaceutical companies.
Bachelor's degree in Chemical Engineering and Chemistry,
Excellent command of Microsoft Office applications,
Fluency in written and verbal English,
Ability to seek and utilize information and solve complex problems,
Effective planning and teamwork skills,
Excellent interpersonal skills in developing effective relationships with other departments,
Excellent interpersonal skills in developing effective relationships with all stakeholders,
No military obligation for male candidates,
Residing in the Asian Side of Istanbul.
İş Tanımı
Preparation and submission of all regulatory documents (GMP inspections and ISO audits, new product submissions/indications, variations, renewals) for medicinal products, medical devices, cosmetics and food supplements to obtain necessary regulatory approvals in due time
Handling the preparation of the registration files and/ or CE Technical Files in high quality to submit to related Authorities
Ensuring that the Company's products comply with the regulations
Speeding up the initiation of the registration procedures
Preparation and submission of price and reimbursement documents in line with the company strategies and within the agreed timeframes
Preparation of responses to the Health and Registration Authorities for maintenance of the current portfolio
Co-ordination and follow-up of all artwork related issues
Preparation and/or revision of relevant SOP's