Regulatory Affairs Executive

JOB DESCRIPTION -

Job Title - Regulatory Affairs Executive

Terms - Full Time Role

Salary - Competitive

Job Timings – 8 AM to 5 PM

Requirements - Graduation in pharmacy background or any relevant degree

About the role -

• To contribute to the regulatory documents and reports to be included in regulatory submission.
• Documents and track regulatory submission and regulatory authority license approval for EU market and most probably Germany.
• Provide regulatory support to the teams and associates of the company.

Responsibilities -

• Application for new registration to receive license from EMA.
• Cooperation with authorities (e.g. BfArM, PEI, EMA, EC)
• New registrations/manufacturer sampling electronic PI submissions
• Create sample packaging (outer packaging, labels, package insert)
• Create manufacturing instructions as per EU legislation and receipt of approval from MAH.
• Maintenance of existing approvals and maintaining formats and content review of packaging texts, SmPC, PIL and labelling.
• Review task for, support and mentor Regulatory Affairs associates.
• Provide on-going regulatory support to the regulatory affairs team lead and to project teams to ensure regulatory concerns are planned and accounted for the relevant data are generated to meet project objectives.
• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflet and labelling.
• Contribute to data entry in softwares, Control that invoicing is correctly done
• 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 skills and leadership
• Excellent organizational and interpersonal skills.
• confident use of MS Office and Multi-tasking
• Effective oral and written communicational skills.
• Proactive attitude and able to work on own initiative as well as part of team.
• Ability to prioritized different workloads/multi tasks
• 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