Senior Specialist, Regulatory Registration and Compliance

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

📋 Description

• Prepare and oversee the marketing authorization (MA) submissions, which includes creating local administrative documents, conducting quality control (QC), and compiling necessary materials.

• Offer ad hoc regulatory guidance regarding submission packages during the post-authorization phase of the medicinal product lifecycle.

• Evaluate and provide linguistic feedback for local Product Information and Mock-ups.

• Act as the main point of contact for regulatory affairs (RA) issues with national competent authorities (NCAs) and/or clients.

• Participate in project management for the network of local contacts concerning Regulatory affairs.

• Gather, process, and manage regulatory intelligence to ensure the organization stays updated on significant changes and developments.

• Suggest marketing authorization strategies customized to meet client requirements.

• Serve as a deputy for the line manager when necessary, guaranteeing smooth continuity in leadership and operations.

⛳️ Requirements

• A university degree in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology.

• Previous experience in the industry is a must.

• Familiarity with the Regulatory landscape and relevant legal and other requirements (both local and global) within the pharmaceutical sector.

• Exceptional organizational abilities, with proficiency in managing multiple projects and meeting deadlines.

• A collaborative attitude, along with outstanding communication skills to effectively interact with clients and regulatory agencies.

• Proficient in English, both written and spoken.

• Experience with centralized procedures is a plus.

• Familiarity with regulatory databases and dossier management software is advantageous.

🏝️ Benefits

• Opportunities for training and career advancement within the company.

• Strong focus on personal and professional development.

• A welcoming and supportive workplace atmosphere.

• The chance to collaborate with colleagues from around the globe, with English as the primary language of communication.