Regulatory Affairs Executive

Astute Healthcare Ltd.; United Kingdom; On-site; GBP 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs professional to join their dynamic team. In this role, you will contribute to regulatory documents and reports, manage submissions, and provide essential support to ensure compliance with EU regulations. The position offers an exciting opportunity to work in a collaborative environment that values diversity and innovation. With a focus on career growth and a comprehensive benefits package, this role is perfect for proactive individuals who thrive in a fast-paced setting. If you are ready to make an impact in the healthcare sector, this position is for you.

Benefits

Competitive Salary

Performance-Based Incentives

Health Insurance

Career Growth Opportunities

Dynamic Work Environment

Inclusive Culture

Qualifications

• Master's degree or higher in a science-related field required.
• Strong organizational and interpersonal skills are essential.

Responsibilities

• Manage regulatory submissions and approvals for the EU market.
• Provide regulatory support and mentorship to associates.
• Create packaging and manufacturing instructions per EU legislation.

Skills

Coordination Skills

Leadership Skills

Organizational Skills

Interpersonal Skills

Oral Communication

Written Communication

Multitasking

Proactive Attitude

Education

Master's Degree in Science

Graduation in Pharmacy or Relevant Degree

Tools

MS Office

Job description

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.