Sr. Spclst, Regulatory Affairs

Job Description

Responsible for supporting the registration maintenance labeling and compliance of assigned products in line with local and regional regulatory requirements. Builds strong relationships with health authorities and internal stakeholders to ensure timely approvals continued compliance and effective regulatory support for business needs.

Key Responsibilities

• 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

• Masters 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:

Preferred Skills:

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