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Clinical Development Project Manager at Harvey Brockless

London, London - England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

21 Dec, 26

Salary

65000.0

Posted On

22 Sep, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Hospitals & Health Systems

Description

Key ResponsibilitiesSupport the development and execution of local and regional regulatory strategies.
Plan, prepare, and manage regulatory submissions in accordance with local regulations and internal standards.
Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
Provide regulatory guidance to support product development, approvals, and lifecycle maintenance.
Develop and maintain local product labeling in line with legislative requirements.
Act as a key point of contact with health authorities and regulatory agencies.
Monitor changes in regulatory legislation and communicate potential impacts to internal stakeholders.
Support regulatory compliance commitments, including post-approval requirements and agency commitments.
Participate in the preparation and submission of safety-related communications when required.
Review and approve promotional and non-promotional materials for regulatory compliance.

Responsibilities

Key ResponsibilitiesSupport the development and execution of local and regional regulatory strategies.
Plan, prepare, and manage regulatory submissions in accordance with local regulations and internal standards.
Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
Provide regulatory guidance to support product development, approvals, and lifecycle maintenance.
Develop and maintain local product labeling in line with legislative requirements.
Act as a key point of contact with health authorities and regulatory agencies.
Monitor changes in regulatory legislation and communicate potential impacts to internal stakeholders.
Support regulatory compliance commitments, including post-approval requirements and agency commitments.
Participate in the preparation and submission of safety-related communications when required.
Review and approve promotional and non-promotional materials for regulatory compliance.