Regulatory Affairs Manager

Biogen

Regulatory Affairs Manager responsible for local submissions and managing regulatory operations in Turkish pharmaceutical context. Collaborating with Health Authorities and internal stakeholders for compliance.

Posted 4/16/2026full-timeIstanbul • 🇹🇷 TurkeyMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Lead local regulatory submission activities for new marketing authorization applications, lifecycle management activities, label changes, technical updates, packaging updates, and post-approval variations for assigned products
Prepare, compile, and submit local dossiers in line with Turkish legislation and Health Authority requirements, ensuring high quality and timely delivery
Manage daily interactions with Turkish Health Authorities, including TİTCK/MoH, to support approvals, respond to questions, and close regulatory follow-up activities
Design and execute GMP strategies, prepare GMP files, support inspections, manage renewals, and ensure timely GMP approvals
Coordinate regulatory timelines and provide strategic regulatory guidance to internal stakeholders, ensuring alignment with commercial priorities and business objectives
Support labeling, artwork development, Turkish translations, packaging compliance, and product information updates in line with local requirements
Monitor and communicate changes in Turkish pharmaceutical legislation, regulatory policies, and packaging guidelines, providing proactive regulatory intelligence to the business
Build strong partnerships with local commercial teams, Medical, Market Access, distributors, global regulatory colleagues, and external stakeholders
Maintain regulatory compliance across marketed products, ensuring all activities are performed according to local and corporate standards
Help navigate a fast-paced and evolving environment where processes may not always be fully established, bringing a proactive and solution-oriented mindset

Requirements

What you’ll need

Health Related sciences background and education (B.A or B.S; advance degree such as Masters’ would be a plus)
A minimum 5-7 years’ experience in Regulatory Affairs in Türkiye
Broad knowledge of Türkiye’s pharmaceutical legislation
Strong ability to understand, interpret and apply local regulations, guidelines, policy statements, and influencing/ advising the operations accordingly
Proven hands-on experience managing GMP submissions, GMP certificates, inspections, and Health Authority interactions
Good experience in interfacing with relevant regulatory authorities
Effective and positive interactions with regulatory agencies, and external network
Ability to assimilate new knowledge rapidly and deep understanding of cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas to enable position holder to discuss compound
Good Analytical skills, accuracy and reliability
Ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills both internally and externally across functions
Strong organizational, project management, and problem-solving skills
Excellent written and verbal communication skills in both Turkish and English

Benefits

Comp & perks

Competitive salary
Flexible working hours
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionGMP strategiesGMP submissionsGMP certificatesregulatory compliancelabel changespackaging compliancelocal dossierspharmaceutical legislationcross-functional drug development

Soft Skills

problem-solvingorganizational skillsproject managementeffective communicationpersuasive skillsnegotiating skillsanalytical skillssolution-oriented mindsetability to assimilate new knowledgepositive interactions

Certifications

B.AB.SMasters