Senior Regulatory Affairs Specialist CIS

Job Description

Join a dynamic Regulatory Affairs team working with CIS countries where you will play a key role in bringing innovative medicines to patients and ensuring compliance throughout the product lifecycle. This position offers the opportunity to work on product registrations regulatory strategy labeling and compliance activities while collaborating with cross-functional teams and health authorities.

Key Responsibilities

• Prepare submit and manage marketing authorization applications and regulatory submissions for assigned products.

• Support product lifecycle management including variations renewals labeling updates and other post-approval activities.

• Coordinate responses to regulatory authority questions and support product approvals and launches.

• Prepare review and maintain local labeling documentation and packaging materials in compliance with regulatory requirements.

• Manage artwork implementation and ensure alignment with approved product information.

• Maintain regulatory records databases and tracking systems to ensure accurate and audit-ready documentation.

• Monitor regulatory changes and assess their impact on products and business activities.

• Provide regulatory guidance and support implementation of new regulatory requirements and procedures.

Qualifications & Experience

• Masters degree in pharmacy Life Sciences or a related scientific discipline.

• Minimum 4 years of experience in Regulatory Affairs product registration or pharmaceutical regulatory compliance.

• Strong knowledge of local pharmaceutical regulations registration procedures and compliance requirements for medicinal products.

• Proven experience with marketing authorization applications and lifecycle management activities.

• Experience in labeling management artwork review and regulatory documentation.

• Familiarity with regulatory databases document management systems and digital regulatory tools.

• Experience interacting with health authorities and managing regulatory submissions.

• Proficiency in English and the local language both written and spoken.

Required Skills:

Preferred Skills:

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