About This Role

The Regulatory Affairs Manager will work in close collaboration with the Türkiye Regulatory and commercial organization, the International Growth Markets (IGM) team within Global Regulatory Affairs (GRA), Chemistry, Manufacturing and Control (CMC) regional contacts, and other relevant local stakeholders.

Under the supervision of the Head of Regulatory Affairs – Türkiye, the incumbent will support the execution of regulatory activities for the assigned portfolio to ensure submissions and approvals of new marketing authorization applications (MAAs) and post-registration variations within agreed timelines.

The role will also be responsible for supporting local regulatory operations, including lifecycle management activities, GMP processes, label updates, packaging updates, and communication with Turkish Health Authorities.

• This role reports directly to the Head of Regulatory Affairs
• Türkiye and can be based either in İstanbul or Ankara.

What You'll Do:

• 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.

Who You Are

You are an experienced Regulatory Affairs professional with strong operational expertise in Türkiye, including dossier preparation, GMP activities, lifecycle management, labeling updates, packaging changes, and Health Authority interactions. You are resilient, adaptable, and comfortable working in an environment where not everything is fully established and where challenges may arise unexpectedly. You have a positive attitude, take ownership, and are willing to explore solutions even when facing unfamiliar situations. You are collaborative, culturally aware, proactive, and able to build strong relationships across functions while managing multiple priorities effectively.

Required Skills

• 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

• Proven track record of fast-track registrations i Türkiye. 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.

Job Level: Management

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.