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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Principal Responsibilities:
Compile and review regulatory submissions for timely registration of new products & on-time renewal of registered
products.
• Develop timelines coordinate receipt of technical information from global RA and execute new product registrations
and renewals under minimal guidance.
• Review technical documents before submission to external party and/or Health authority to ensure the documents
meet and/or fulfil the country requirement/request.
• Monitor and update registration activities and/or status to all relevant stakeholders on a regular basis. Ensure the
required actions and responses are in place in a timely manner .
• Demonstrate strong understanding of MDR 2017 and associated regulations (LMR DPCO Drugs and Magic remedies
Act etc.).
• Provide support to Institution business team on tender related requests.
• Provide necessary support in preparing Form-VI/IPDMS update as part of mandatory NPPA reporting under DPCO
2013. (both scheduled and non-scheduled formulations).
• Providing support to manager in activities/task related to environmental compliance.
• Work closely with internal/external stakeholders to ensure requirements and business priorities are proactively
communicated and planned.
• Lead cross-functional discussions with Supply chain planning and L&D operations team to maintain uninterrupted
business continuity.
• Provide timely intel to reporting manager in sending out key communication internal document modification to
ensure minimal/no impact to business .
• Monitor changing/new requirements and prepare policies guidelines training for employee to ensure awareness
and timely implementation of same.
Education / Experience Requirements:
The ideal candidate would have a diploma/degree in a scientific discipline such as Biology Microbiology Pharmacy
pharmacology Biotechnology engineering or medical technology.
• Minimum 5 years of experience in Medical devices regulatory affairs and 7-8 years of working experience in a Medical
devices/Pharmaceutical company.
• Good working knowledge of MS-EXCEL and PowerPoint will be preferred.
BEHAVIOUS / VALUES
• Team player having an analytical and problem-solving mindset.
• Highly motivated willing to learn and having an open mindset.
• Must be approachable and have a positive mindset
• Flexible and adaptable to changing environment and needs
• Must be a patient listener and have a rational mindset towards solving problems.
• Demonstrate strong integrity in dealing with different external stakeholders
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
