Sr. Spclst, Regulatory Affairs

Overview

• Responsible for supporting the registration, maintenance, labeling, and compliance of assigned products in line with local and regional regulatory requirements.
• Prepare, submit, and follow up on new Marketing Authorization applications with local authorities.
• Maintain product licenses through variations, renewals, and supplemental applications.
• Ensure timely, accurate, and compliant labeling translations and artwork preparation.
• Support Clinical Trial Applications and agency interactions in cooperation with internal stakeholders.
• Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments,
• Monitor regulatory updates, guidelines, and pipeline developments; assess business impact and support action planning.
• Collect and share relevant regulatory intelligence.
• Support business initiatives through collaboration with local, regional, and global teams.
• Maintain effective relationships with internal teams and external regulatory authorities.
• Support compliance activities, including product information, artwork, databases, and regulatory archives.
• Contribute to SOPs, regulatory documentation, and implementation of updated requirements.
• Provide regulatory input to cross-functional projects, launches, pricing and reimbursement activities, and quality-related matters.
• If applicable, manage and develop direct reports, including coaching, training, and workload prioritization.

Qualifications & Experience

• Master s degree in pharmacy, life sciences, or a related field.
• Minimum 4 years experience in regulatory registration
• Experience dealing directly with regulatory authorities.
• Strong knowledge of local and EU pharmaceutical regulations and procedures.
• Excellent communication, organization, and planning skills.
• Strong attention to detail and ability to manage multiple priorities.
• Ability to work collaboratively and influence internal and external stakeholders.
• Proficiency in local language and English, plus standard PC applications.

Required Skills