Regulatory Affairs Specialist
6 days ago
As a Regulatory Affairs Specialist at Quanta Consultancy Services Ltd, you will be responsible for maintaining manufacturing operations and ensuring compliance with regulatory obligations.
Main Responsibilities:
- Obtain and maintain marketing authorisations for designated territories to ensure on-time launches and continued supply.
- Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations.
- Advise senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines.
- Maintain awareness of regulatory requirements, including legislation, guidelines, and industry best practice.
- Develop and implement strategies for product registrations, including strategy/planning, registrations, monitoring, post-marketing approvals, and launching in accordance with EU regulations.
- Collaborate with cross-functional teams to ensure effective prioritisation and alignment with company requirements.
Requirements:
- Extensive experience in EU Regulatory Affairs, with a proven track record of full lifecycle product registrations.
- Strong understanding of EU regulations and industry best practices.
- Excellent communication and project management skills.
- Ability to work in a fast-paced environment and adapt to changing priorities.
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