Senior Regulatory Affairs Associate

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Provide local regulatory insights to aid in the development of regulatory strategies for new product registrations and lifecycle management efforts.

• Monitor and relay regulatory progress to stakeholders.

• Ensure adherence to local regulatory standards and engage in policy-related initiatives with industry organizations and trade associations.

• Keep up-to-date with local regulatory requirements, guidelines, and industry advancements.

• Facilitate interactions with health authorities, partners, vendors, and commercial teams.

• Prepare, organize, and coordinate local regulatory documentation and submission components specific to the country.

• Manage local regulatory systems to align with legislation.

• Assist in the application and interpretation of local laws and regulations.

• Conduct reviews of promotional materials and execute operational regulatory tasks.

• Collaborate with regional regulatory teams on submission processes.

• Represent regulatory concerns for local commercial operations and communicate received regulatory approvals.

• Maintain regulatory information management systems and oversee compliance activities.

• Aid in timely renewals, post-approval submissions, regulatory commitments, labeling updates, translations, and the review of promotional materials.

• Participate in face-to-face meetings with relevant Health Authority representatives.

⛳️ Requirements

• A relevant bachelor's degree or equivalent secondary education in a scientific field such as biology, chemistry, or a related area with a focus on pharmacology.

• Over 5 years of regulatory experience with Turkish health authorities in a regulatory affairs capacity.

• A robust understanding of regional and global regulatory requirements, guidelines, and processes.

• Proven experience in managing regulatory submissions, timelines, and cross-functional activities to achieve successful product registrations and compliance targets.

• Extensive expertise in engaging with and managing local health authorities.

• Excellent communication, organizational, time management, and problem-solving abilities within a global context.

• Proficient in both the local language and English, in written and spoken forms.

• Advanced skills in Microsoft Office.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Vacation/Holiday/Sick Time.

• Flexible benefits portal.

• Flexible work arrangements.

• Opportunities for growth.