Biogen

Regulatory Affairs Manager

Biogen

full-time

Posted on:

Location Type: Hybrid

Location: Istanbul • Turkey

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About the role

  • 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

  • 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
  • Competitive salary
  • Flexible working hours
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

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