Temporary Regulatory Affairs Specialist

Company Name: Randstad Türkiye
Location: Turkey

We are looking for a Regulatory Affairs Specialist to our global company.

Knowledge, Experience and Skills:
• Bachelor degree in Pharmacy, Chemical Engineering, Chemistry, Biology or other related
Health/Life Sciences. Pharmacy degree will be an advantage.
• Minimum 4 years of relevant experience in Regulatory Affairs, preferably in a multinational
Company.
• General understanding of regulatory requirements, including ICH requirements and Turkish
reguirements. Experience and general understanding of clinical trial related submissions to
Health Authorities will be an advantage.
• Fluency in written and verbal English.
• Excellent organizational, communication and interpersonal skills.
• Strong follow up & time management skills
• Collaboration and active communication
• Proficiency in MS Office software (Word, Excel, PowerPoint, Outlook)

Responsibilities:
• Preparation and submission of regulatory applications (e.g. CMC variations, labeling
updates, renewals, MoH response letters etc.) for assigned products in line with regional
requirements; scientific and company policies/procedures.
• GMP inspection submissions for assigned products inc. renewals, maintenance related
applications.
• Represent Regulatory Affairs on internal and external cross-functional teams (e.g., RST),
providing regulatory affairs support for investigational and/or marketed products, as
assigned.
• Liaise with Pharmacovigilance and Epidemiology (PVE) and International Regulatory
Affairs regarding submission of DSUR, PSUR/PBRER, DHPL, urgent safety restrictions
and safety variations.
• Obtain and maintain necessary regulatory-associated licences and obligations with Turkish
Agency in order to allow company to conduct its business.
• Providing support for clinical trial applications, e.g. initial submission, amendments,
packaging, import permits, archiving&tracking etc…).
• Provision of accurate English translations of all agencies correspondence and labelling for
company’s products in Russia and EAEU.
• Work within the department and with other functional areas on process improvements.
• Keeping Company and Ministerial databases updated; follow Company procedures for
regulatory applications during pre-/post approval phase.
• Submitting import permission applications to MOH, also submitting actual import
notifications.
• Provide regulatory input to cross-functional projects; contribute to routine local process
improvements, which have an impact on the working of the Regulatory Affairs function (e.g.
meeting minutes tracking, maintenance of local archive system and raising POs etc).
• Ensure compliance to company policies/ procedures for all types of regulatory submissions,
inc. database updates, archiving etc.
• Artwork (outer box and leaflet) coordination, controls and approvals for assigned products
• Review of promotional materials where required.

• Seniority level

  Associate

• Employment type

  Full-time

• Job function

  Purchasing

• Industries

  Human ResourcesOil & Energy