Regulatory Affairs Manager

3 days ago


Fatih, Istanbul, Turkey Er-Kim Full time

Our company is seeking a dedicated Regulatory Affairs Manager to join our Regulatory Affairs Department. If you're ready to make a global impact and drive compliance excellence, we want you on our team in Istanbul.

Responsibilities
  • Contribute to the preparation of registration and variation files according to current Ministry of Health requirements,
  • Contribute to the preparation of food supplement dossiers according to current Ministry of Agriculture requirements,
  • Contribute to the preparations of pricing submissions & reimbursement dossiers of products,
  • Provide for receiving approval of registrations and sales permissions,
  • Preparation of SmPC/PIL submissions,
  • Manage the written correspondence with Ministry of Health before and after registration approval,
  • Follow up global and local regulatory requirements,
  • Maintain and update global and local regulatory systems,
  • Providing support to the Import Department regarding required registration documentation,
  • Develop a team of Regulatory Specialists and principals. As team manager, ensures that team members receive appropriate training, coaching and development plan,
  • Support the team to prioritize and plan on product registrations/renewals/variations cadence in line with the business strategy,
  • Report to the Regulatory Affairs Director,
  • We expect your English language skills to be relevant in collaborating with your colleagues as well as internal and external stakeholders on a global basis.
Qualifications
  • Graduated from the Pharmacy, Chemistry, Chemical Engineering and Biology departments of universities,
  • Advanced command of written and spoken English,
  • Preferably regulatory work experience in a pharmaceutical company:
  • Min 5 years of Regulatory Affairs experience for Manager position
  • Advanced knowledge in MS Office applications,
  • High interpersonal, communication and presentation skills,
  • Good at teamwork,
  • Good at follow-up and strong planning skills,
  • No restriction for travel.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

Pharmaceutical Manufacturing

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