Regulatory Compliance Officer

4 weeks ago

Glasgow, United Kingdom CDM Recruitment Full time
Position: Regulatory Compliance Officer

Location: Remote

Contract Type: Contract

Job Overview:

CDM Recruitment is seeking experienced Regulatory Compliance Officers with expertise in Investigational Medicinal Products (IMPs) and commercial operations to join our dynamic team on a contract basis.

In this role, you will be responsible for managing legal and routine responsibilities related to the evaluation, approval, and certification of both licensed and investigational pharmaceutical products.

Reporting directly to the Quality Assurance Manager, you will ensure that quality standards are upheld for both internal and external manufacturing and testing processes, aligning with local and international regulatory frameworks.

Key Responsibilities:
  • Executing compliance duties in accordance with the Human Medicines Regulations and EU guidelines.
  • Authorizing product batches following established protocols.
  • Evaluating deviations and implementing corrective measures.
  • Providing necessary documentation for product certification to ensure market readiness while adhering to applicable regulations.
  • Staying informed about current and forthcoming legislation impacting pharmaceutical manufacturing.
  • Understanding the requirements for product licensing.
  • Proposing improvements to enhance the efficiency of the batch release process.
  • Acting as a pivotal resource in resolving product quality concerns, offering training, operational support, and technical expertise to team members.
  • Regularly assessing the batch certification process for compliance and efficiency improvements.
  • Identifying emerging regulatory requirements and developing action plans for compliance.
  • Collaborating with systems to ensure timely identification and resolution of quality and regulatory compliance issues.
  • Conducting audits to ensure compliance with Good Manufacturing Practices (GMP).
  • Exhibiting comprehensive knowledge of GMP, Good Distribution Practice (GDP), and Good Clinical Practice (GCP).
  • Performing audits in GMP/GDP/GCP/ISO environments.
  • Being well-versed in regulatory and ISO inspection processes.
  • Understanding global standards for pharmaceutical manufacturing.
  • Working within Quality Management Systems and recognizing their significance in a pharmaceutical context.
  • Making informed recommendations and decisions based on data analysis.
  • Effectively presenting information to diverse audiences.
  • Demonstrating strong persuasive skills.
Qualifications:
  • Registered/Qualified to act as a Regulatory Compliance Officer in the UK.
  • Minimum of 5 years of experience in a pharmaceutical batch release environment.
  • Proficient in the release of Investigational Medicinal Products (IMPs), including biologics and sterile formulations.

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