Strategic Regulatory Affairs Manager

Novo Nordisk A/S

Fatih

On-site

TRY 900,000 - 1,300,000

Full time

2 days ago

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Job summary

Novo Nordisk Turkey is seeking an experienced Regulatory Affairs Manager to lead regulatory strategies for Novo Nordisk products in Turkey, based in Istanbul. You will manage registrations, variations, labelling and safety updates, coordinating with HQ and local authorities for timely approvals.

You will build cross-functional partnerships, monitor regulatory changes, and represent Regulatory Affairs in brand teams, ensuring compliance with local procedures and global standards.

Qualifications

University degree in Pharmacy, Chemical Engineering, Chemistry, Biology or Medical.
8–10 years of proven regulatory affairs experience in pharma.
Advanced written and spoken English and Turkish.

Responsibilities

Develop regulatory strategies for innovative products and manage internal/external stakeholders.
Prepare and submit registration files, plan variations, renewals, and labelling updates.
Lead GMP-related activities and respond to regulatory modifications from HQ/local authorities.
Represent Regulatory Affairs in brand teams and collaborate cross-functionally for approvals.
Monitor regulatory developments and provide guidance to internal stakeholders.

Skills

Regulatory strategy

Stakeholder management

English and Turkish

Project management

Analytical thinking

Education

University degree in Pharmacy / Chemistry / Biology / Medical

Tools

Regulatory databases

Document management systems

Job description

You will build cross-functional partnerships, monitor regulatory changes, and represent Regulatory Affairs in brand teams, ensuring compliance with local procedures and global standards.

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