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Regulatory Affairs Specialist
2 months ago
Kindeva Drug Delivery Company is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with global regulatory requirements and providing strategic planning for regulatory changes.
Key Responsibilities- Manage regulatory compliance activities for Kindeva and existing customer products and registrations.
- Act as the regulatory lead for site-specific activities, including Quality Reviews and Change Committees.
- Coordinate and prepare regulatory documentation for clinical trial applications, Drug Master Files, and registration CTD documents.
- Manage or mentor more junior staff to achieve business and role goals and objectives.
- Provide input and direction to the site and wider Kindeva business on regulatory matters.
- Provide regulatory support to team members on specific project issues, ensuring alignment with global guidelines and legislation.
- Manage and/or mentor members of the regulatory team as required.
- Advise internal and external stakeholders on likely regulatory requirements associated with planned and unplanned changes.
- Participate in technical reviews of data to ensure alignment with current global guidelines and regulatory needs.
- Manage regulatory authority meetings, including preparing briefing documentation and presentations.
- Membership of project teams, including estimating regulatory resource needs and monitoring regulatory activities.
- Attend customer-focused meetings and interface with regulatory contacts at the customer company.
- Communicate regulatory learnings from other projects to ensure continuous improvement.
- Advise on CMC elements of variation/supplement packages as required.
- Communicate expectations of approval timelines within the organization.
- Provide regulatory leadership for site-specific activities.
- Monitor developing and evolving global regulatory guidelines and provide assessments of implications.
- Recruit, train, mentor, motivate, and develop the team.
- Ensure continued personal development and maintain current knowledge of requirements for the role.
- Graduate in pharmacy or a life science (or equivalent).
- Additional regulatory qualifications advantageous.
- 7+ years relevant experience of US, European or Global registration procedures.
- Able to communicate effectively orally and in writing.
- Able to work both as part of a cross-functional team and act independently.
- Enthusiastic and determined to achieve set objectives.
- Comfortable working with detailed technical information and able to see the overall picture.
- Possess strong computer skills and excellent organizational capabilities.
- Demonstrate flexibility, strategic thinking, and drive to succeed.
- Able to deliver results accurately within demanding time frames.
- Able to handle a crisis in a professional and positive manner.
- Able to communicate effectively with colleagues at all levels.
