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Healthcare Compliance Manager

2 months ago


Harefield, Greater London, United Kingdom Norgine Full time
About the Role

Norgine is seeking a highly skilled Healthcare Compliance Manager to join our Consumer Healthcare division. As a key member of our team, you will be responsible for developing, implementing, and overseeing compliance activities related to consumer health products.

Key Responsibilities
  1. Compliance Programme Development and Implementation

Develop and maintain comprehensive compliance programmes related to consumer health, ensuring adherence to EU and local regulations, industry standards, and codes of practice.

Regulatory Monitoring and Reporting

Conduct horizon scanning for changes in relevant regulations, assess their impact, and update compliance programmes accordingly. Prepare and submit compliance reports as required.

Training and Education

Promote and deliver compliance training programmes to educate staff on compliance requirements, best practices, and industry codes of practice.

Risk Management

Identify and assess compliance risks related to consumer health products, support risk mitigation strategies, and conduct regular compliance risk assessments and audits.

Audit and Inspection Coordination

Coordinate and manage audits and inspections, ensuring timely and effective resolution of any compliance issues identified.

Collaboration and Communication

Work closely with legal, regulatory, marketing, and other departments to ensure integrated compliance efforts.

Documentation and Record-Keeping

Maintain comprehensive records of compliance activities, investigations, and resolutions, ensuring documentation meets regulatory standards and company policies.

Ethics and Integrity

Promote a culture of ethics and integrity within the organisation, addressing and resolving any compliance-related ethical issues.

Requirements
  • Minimum of 3 years of experience in healthcare compliance within the consumer health industry, ideally with experience in more than one country.
  • In-depth knowledge of European consumer healthcare regulations and compliance requirements.
  • Familiarity with pharmaceutical advertising, promotional regulations, and industry codes of practice.
  • Proven ability to develop and implement effective compliance programmes.
  • Excellent communication and training skills.
  • Strong analytical and problem-solving abilities.
  • Experience with digital health compliance.
  • Ability to think strategically and assess compliance risks, manage and escalate in a proportionate manner.
  • Display emotional intelligence and diplomacy to work with senior management and other roles in the business.