Strategic Regulatory Affairs Manager — Istanbul

Novo Nordisk; Fatih; On-site; TRY 420,000 - 640,000; Full time

Job summary

Novo Nordisk Turkey is seeking a Regulatory Affairs Manager in Istanbul to lead regulatory strategies for innovative products, manage internal and external stakeholders, and represent Novo Nordisk in industry associations.

You will oversee new registrations, plan technical variations, renewals, labeling and safety updates of registration files and GMP processes, and respond to requests from HQ and local authorities.

Qualifications

• University degree in Pharmacy, Chemical Eng, Chemistry, Biology or Medical.
• 8–10 years in regulatory affairs in pharma.
• Advanced written and spoken English and Turkish.
• Strong project management and stakeholder management skills.
• Knowledge of ICH guidelines, EU regulations, and Turkish pharma regulation.
• Proficiency with regulatory databases and document management systems.

Responsibilities

• Develop regulatory strategies for innovative products and manage stakeholders.
• Lead registration files, plan variations, renewals, labeling, and safety updates.
• Represent Novo Nordisk in industry associations and coordinate cross-functional teams.
• Monitor regulatory developments and ensure compliance with local regulations.

Skills

Regulatory affairs

Pharma industry

Stakeholder management

English (advanced)

Turkish (advanced)

Education

Pharmacy / Chemical Engineering / Chemistry / Biology / Medical degree

Tools

Regulatory databases

MS Office

Job description

Novo Nordisk Turkey is seeking a Regulatory Affairs Manager in Istanbul to lead regulatory strategies for innovative products, manage internal and external stakeholders, and represent Novo Nordisk in industry associations.

You will oversee new registrations, plan technical variations, renewals, labeling and safety updates of registration files and GMP processes, and respond to requests from HQ and local authorities.