Regulatory Affairs Executive

Salary:

Competitive

Job Timings:

8 AM to 5 PM

Requirements:

Graduation in pharmacy background or any relevant degree.

About the Role:

• Contribute to regulatory documents and reports for regulatory submission.
• Document and track regulatory submissions and regulatory authority license approvals for the EU market, particularly Germany.
• Provide regulatory support to the teams and associates of the company.

Responsibilities:

• Apply for new registrations to receive licenses from EMA.
• Cooperate with authorities (e.g., BfArM, PEI, EMA, EC).
• Manage new registrations and manufacturer sampling electronic PI submissions.
• Create sample packaging (outer packaging, labels, package insert).
• Create manufacturing instructions as per EU legislation and obtain approval from MAH.
• Maintain existing approvals and review formats and content of packaging texts, SmPC, PIL, and labeling.
• Review tasks, support, and mentor Regulatory Affairs associates.
• Provide ongoing regulatory support to the regulatory affairs team lead and project teams to ensure regulatory concerns are addressed and relevant data is generated to meet project objectives.
• Conduct format and content reviews of packaging texts, Summary of Product Characteristics, Patient Information Leaflet, and labeling.
• Contribute to data entry in software, ensuring accurate invoicing.
• Assist the RA platform or hub leader or Coordinator in presales.

Candidate Requirements:

• Master’s or higher graduate degree in a science-related field.
• Strong coordination and leadership skills.
• Excellent organizational and interpersonal skills.
• Confident use of MS Office and ability to multitask.
• Effective oral and written communication skills.
• Proactive attitude and ability to work independently as well as part of a team.
• Ability to prioritize different workloads and multitask.
• Personal responsibility for ensuring a high standard of work.

Benefits:

• Competitive salary and performance-based incentives.
• Comprehensive benefits package including health insurance.
• Opportunities for career growth and advancement within a global organization.
• Dynamic and collaborative work environment with a diverse and inclusive culture.

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