Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Governance and Compliance Lead ensuring regulatory compliance and quality assurance in healthcare services at Montu UK. Collaborating with teams to enhance governance and service improvement.
Responsibilities
- Collaboration with teams across the company
- Data mapping
- Audits (clinical and non-clinical)
- Quality assurance
- Incident Management and support
- Risk Assessments, Analysis, Management and Support
- Complaints handling and support
- Support and lead in operations/governance projects
- Support or lead in the management and development of policies and procedures
- Supporting or lead change management
- Scheduling and minuting of meetings as required
- Cascading governance related information internally
- Supporting with all aspects of governance and compliance across all teams
- Service improvement and development
- Deputising for the Head of Governance
Requirements
- Educated to degree level or qualified by demonstrable experience- in a clinical area
- Experience of regulatory requirements and compliance, legal interactions, procurement, insurance, and contracts
- Able to investigate, manage and create actionable service improvement plans through incident/deviation management
- Experience of creation and delivery of training programmes
- The ability to research best practices and support implementation across teams.
- The ability to manage the operational aspect of the role regarding governance and compliance
- The ability to learn and develop quickly
- Excellent organisation skills, attention to detail and a systematic thinker
- Holds or is willing to work towards a recognised qualification in Governance / Risk management
Benefits
- Competitive salary
- 25 days holiday (rising to 27 after one year, rising to 30 after two years) + bank holidays
- 5% matched pension
- Cycle-to-work scheme
- Enhanced Maternity & Paternity Leave
- Opportunities for development and growth
- A dynamic and supportive work environment
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