Senior Regulatory Affairs Manager

On behalf of our client, a successful global pharmaceutical company, Adecco is seeking an experienced candidate for the position of:

Senior Regulatory Affairs Manager

Location: Belgrade

Key Responsibilities:

• Lead and coordinate regulatory activities to ensure full compliance with local regulations, internal standards, and applicable quality requirements.

• Manage the preparation, review, submission, and maintenance of regulatory documentation throughout the product lifecycle.

• Oversee the implementation of approved product information and labeling updates, ensuring accuracy and timely execution.

• Provide regulatory guidance and expert support to cross-functional teams, contributing to successful product launches and business initiatives.

• Act as a key contact during regulatory inspections, audits, and interactions with health authorities.

• Monitor regulatory developments and assess the impact of new legislation, guidelines, and internal policies on business operations.

• Drive continuous improvement initiatives by optimizing regulatory processes and supporting the development and implementation of procedures.

• Lead or participate in local, regional and global regulatory projects, ensuring efficient execution and achievement of business objectives.

• Mentor junior colleagues and contribute to the development of regulatory capabilities within the team.

Candidate profile:

• University degree in Pharmacy or a related field.

• Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry.

• Experience working in a highly regulated environment, with solid knowledge of risk management principles, process improvement methodologies, and regulatory procedures.

• Excellent command of English, both written and spoken.

• Proficiency in business software and digital tools, including MS Office applications and ERP systems.

• Strong regulatory expertise combined with business acumen and the ability to think strategically.

• Excellent planning and organizational skills, strong attention to detail, and highly developed written communication abilities.