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Temporary Regulatory Associate

TW Bilgi ve İletişim Hizm. A.Ş.

İstanbul(Avr.), İstanbul(Asya)

İş Yerinde

İş Yerinde

Job Type

Periodical

Years of Experience

More than 2 years of experience

Department

Registration

Registration

Application Count

0-50 application

Job Type

Periodical

Years of Experience

More than 2 years of experience

Application Count

0-50 application

Department

Registration

QUALIFICATIONS AND JOB DESCRIPTION

Our business partner, which operates in pharmaceutical sector, is looking for a "Temporary Regulatory Associate”.

 

QUALIFICATIONS:

·         Good knowledge of written and spoken English

·         Relevant scientific degree or Bachelor's degree in pharmacy or life sciences (pharmaceutical, medical, chemical) is required

·         2-4 years experience

 

JOB DESCRIPTION:

·         Obtaining and maintaining product licenses for marketing affiliate by preparing and filing submissions to local regulatory agency, e.g. new products, line extensions, variations (Chemistry, Manufacturing and Control (CM&C), new indications, labelling etc.), renewals, co-marketing and GMP submissions for the inspections

·         Supporting responses and issue resolution with regulators

·         Using and updating corporate regulatory systems e.g. RAPT (Regulatory Activity Planning and Tracking) and RRIC (Regulatory Requirements in Intercontinental Region) as applicable

·         Maintaining complete archive of all MoH communications and all submitted and proposed documents (product dossier, etc.)

·         Beginning to establish relationship with junior officials in the local regulatory agency (via direct interactions or industry associations)

·         Building and maintaining relationships with Medical and Marketing in the affiliate to facilitate submissions and timely update of labeling materials (as appropriate). Gaining support for solutions to standard or small scale issues

·         Responding to queries on regulatory processes and regulatory status

·         Analyzing possible solutions to solve a range of regulatory problems

·         Becoming knowledgeable on all aspects of regulatory affairs and aware of national legislation and guidance as well as some areas of the latest regional legislation and/or ICH guidance if applicable

·         Using appropriate local and global SOPs as required by the Safety and Efficacy Quality System (SEQS) and the applicable Company Quality Standards

·         Performing Affiliate Product Information (API) and Affiliate Drug Information (ADI) labeling tasks such as development of new packaging material, maintaining existing packaging material updated in compliance with Core Labeling and local regulatory requirements and approving packaging material through BLUE system for the products under responsibility

·         Collaboration with GOLD regarding safety and CDS compliance

·         Submitting API labeling changes in due time per instructions communicated by SAIL

·         Maintaining records of locally submitted and approved labeling documents and packaging components

Firmamız Türkiye İş Kurumu'nun 2.11.2018 tarih ve 1006 numaralı izin belgesi ile faaliyet göstermektedir.

 

Preferred Candidate

Bachelor’s(Graduate)
English(Reading : Good, Writing : Good, Speaking : Good)

Ruhsatlandırma Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Ruhsatlandırma Uzmanı Ruhsatlandırma Uzmanı Maaşları Ruhsatlandırma Uzmanı Nasıl Olunur? Ruhsatlandırma Uzmanı Nedir? Ruhsatlandırma Uzmanı İş İlanları

Call center products and services / Human Resources Consultancy

Hakkımızda

‘’Odağımız İnsan’’ Trenkwalder bir Droege Grup iştirakidir. Droege Grubu ise 1988 yılında Almanya’da kurulan, uluslararası alanda 30 ülkede tamamı öz

Şirket Sayfasına Git
Şirketin Aydınlatma Metni

6698 SAYILI KİŞİSEL VERİLERİN KORUNMASI KANUNU (“KVKK”) USUL VE ESASLARI UYARINCA KİŞİSEL VERİLERİN

Detaylı Bilgi
Yan Haklar

Özel Sağlık Sigortası, Servis, Kreş, Yemek Kartı (Setcard, Ticket, Multinet, Sodexo vb.), Prim, Yakacak.

Ruhsatlandırma Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Ruhsatlandırma Uzmanı Ruhsatlandırma Uzmanı Maaşları Ruhsatlandırma Uzmanı Nasıl Olunur? Ruhsatlandırma Uzmanı Nedir? Ruhsatlandırma Uzmanı İş İlanları