Quality and Regulatory Affairs Manager developing and supporting quality management systems for medical devices. Engaging in regulatory processes and facilitating innovation in healthcare.
About the role
- Regulatory Specialist managing submission delivery excellence at GSK. Collaborating with cross-functional teams to meet regulatory guidelines and timelines.
Responsibilities
- Works closely with global submission teams and regulatory contacts to deliver submissions.
- Responsible to deliver marketing applications and lifecycle maintenance submissions including renewals and site registrations.
- Coordinates MSR for various types of submission and executes agreed dossier strategies independently.
- Assists in scenario planning for multiple regulatory strategies.
- Executes coordination, preparation, and delivery of regulatory registration samples in partnership with stakeholders.
- Identifies and escalates risks associated with submission delivery.
- Participates in process improvement initiatives as required.
- Mentors and trains team members as necessary.
Requirements
- Degree in a biological, healthcare or scientific discipline or extensive experience in the Regulatory Affairs area.
- Understanding of the pharmaceutical industry, R&D processes and objectives.
- Ability to interpret regulations.
- Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
- Ability to think flexibly in order to meet shifting priorities and timelines.
- Good organizational skills, attention to detail and commitment to deliver high quality output in a timely manner.
- Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
- Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.
Benefits
- Private healthcare
- Additional paid days off
- Life insurance
- Private pension plan
- Fully paid parental leave & care of family member leave
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