Regulatory Affairs Specialist

About the role

Bilim Pharmaceuticals is looking for a Regulatory Affairs Specialist to join its Regulatory Affairs Department in Beyoğlu. You will be responsible for managing regulatory processes for products in international markets and ensuring compliance with local legislation.

Key responsibilities

• Plan and manage regulatory processes for targeted international markets.
• Prepare and submit EU‑CTD dossiers, monitor country‑specific regulations, and handle license renewals and variations.
• Communicate with official authorities and business partners to ensure smooth progress.
• Coordinate with R&D, Production, Quality Control and other internal teams to keep documentation up‑to‑date.
• Manage product labeling and packaging according to market requirements and track regulatory developments.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or related field.
• 2–3 years of experience in pharmaceutical regulatory affairs, preferably with international markets.
• Advanced proficiency in English, both written and spoken.
• Strong analytical, problem‑solving, communication and negotiation skills.
• Team‑oriented with high organizational and planning abilities.

Required skills

• Preparation of dossiers in EU‑CTD format.
• Proficiency with MS Office applications.