Regulatory Compliance Manager (GCP)

Job Responsibilities:

• You will be able to work with limited supervision and instruction so must be confident auditing independently.
• You will be coordinating and reviewing the work of others in the team.
• Manage and lead others in both routine and complex audit activities involving multiple projects and ensure the activities are completed.
• Identify, define and communicate audit plans for contract auditors and oversees the activities performed by contract auditors and train contract auditors in company procedures.
• Establish relationships and agreements with contract auditors.
• Evaluates departmental and business area SOPs for fit for purpose and in compliance with regulatory requirements.
• Leads intra- or interdepartmental teams of an operational nature such as: preparing the Company for minor changes in regulations, continuous improvement initiatives
• Purpose is for input and obtaining information for dissemination intra- or interdepartmentally.
• Assists in readiness for and regulatory agency inspections. Assists in the coordination of responses to any regulatory agency findings.
• Developing and presenting training using standard modules and training on special topics
• Ensures appropriate content of training modules.
• Initiate operational change where required and communicate change in a positive manner.
• Define systems or processes to consistently ensure the high standards required in Compliance.

Required experience:

• Must have an in-depth knowledge of regulatory requirements for assigned territories.
• Experienced in a variety of GCP audits.
• Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please call Tiffany Gardner on 02039288385 or email: tgardner@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com