Regulatory & Medical Affairs Manager

About the role

Biocodex, a French family-owned pharmaceutical company founded in 1953, is looking for an experienced Regulatory & Medical Affairs Manager to join its team in Turkey. Reporting directly to the General Manager and sitting on the Management Committee, the role leads Medical Affairs, Regulatory Affairs, Pharmacovigilance, Compliance, Market Access, Quality and related functions, while contributing to the company's business strategy and sustainable growth.

Key responsibilities

• Lead and develop Medical Affairs and Regulatory Affairs strategies in line with business objectives, corporate standards and local regulatory requirements.
• Contribute to the Management Committee, supporting strategic planning, business decisions and cross-functional initiatives.
• Develop and implement short- and long-term medical strategies for product positioning, portfolio development and business growth.
• Lead medico-marketing initiatives, ensuring scientific accuracy and regulatory compliance of promotional and educational materials.
• Oversee regulatory submissions, product registration, licensing and lifecycle management under Turkish legislation.
• Build relationships with the Ministry of Health, regulatory authorities, healthcare professionals, key opinion leaders and scientific organisations.
• Run scientific engagement activities such as advisory boards, medical education programmes and scientific events.
• Provide medical and scientific guidance to internal stakeholders and external partners, and lead medical training programmes.
• Evaluate new products, licensing agreements, strategic partnerships and market expansion opportunities.
• Ensure compliance with pharmaceutical regulations, ethical standards and internal policies, and lead, coach and develop multidisciplinary teams.

Required profile

• Bachelor's degree in Medicine, Pharmacy or a related Life Sciences discipline; an advanced degree is preferred.
• At least 10 years of experience in the pharmaceutical industry, including at least 5 years in a Medical Manager role.
• Proven leadership in Medical Affairs, with strong knowledge of Regulatory Affairs and the Turkish pharmaceutical regulatory environment.
• Experience managing cross-functional teams and working with senior management.
• Fluency in written and spoken English and Turkish.

Required skills

• Solid knowledge of pharmaceutical regulations, pharmacovigilance, compliance and medical governance.
• Understanding of medico-marketing, scientific communication and healthcare professional engagement.
• Strategic thinking, analytical and problem-solving skills, and strong communication, negotiation and presentation skills.