Regulatory Affairs Product Lead – Türkiye
Novo Nordisk
contract
Posted on:
Location Type: Office
Location: Istanbul • 🇹🇷 Turkey
Visit company websiteJob Level
Senior
About the role
- developing the regulatory strategy for innovative products
- managing new registration files, technical variations, labelling and safety updates
- responding effectively to all product registration modifications
- conducting translation, compilation, submission and follow-up related to NN registration processes
- ensuring compliance with NN Corporate Quality Procedures, local regulations and business needs
- accompanying GMP inspection with inspector and conducting all GMP processes and communication
- providing input on strategy and actions in internal brand teams
- monitoring competitive intelligence on relevant therapeutic areas and providing relevant information
Requirements
- hold a university degree in Pharmacy, Chemical Engineering, Chemistry, Biology or Medical
- minimum 3 years of proven experience in regulatory affairs in pharma industry
- advanced level of written and spoken English and Turkish
- ability to manage multiple projects and submissions simultaneously
- excellent communication and stakeholder management abilities
- effective time management skills
- good analytical capability and strategical thinking mindset
- eagerness to learn
Benefits
- opportunities to learn and develop are all around us
- our benefits are designed with your career and life stage in mind
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentproduct registrationtechnical variations managementGMP processescompliance assurancesubmission and follow-upcompetitive intelligence monitoringanalytical capabilitystrategical thinking
Soft skills
communicationstakeholder managementtime managementproject managementeagerness to learn
Certifications
university degree in Pharmacyuniversity degree in Chemical Engineeringuniversity degree in Chemistryuniversity degree in Biologyuniversity degree in Medical