Director, Regulatory Compliance

Proclinical is working with a clinical stage biopharmaceutical company that is seeking a Director of Regulatory Compliance to be based in Singapore on a permanent basis.

This position reports directly to the Vice President, Global Regulatory Affairs and Compliance and is responsible for working collaboratively across multi-functions including clinical, manufacturing and quality regarding GxP (GLP, GCP, PV, GMP) compliance to provide strategic GxP compliance support to assure adherence to global health authority requirements. The Regulatory Compliance Leader is responsible for advancing a Compliance Excellence mind set and has a unique opportunity to lead transformational change to a culture of excellence and working across the functions within the organization to streamline the integrated approach to quality and compliance throughout the product lifecycle.

Job Responsibilities:

• Ensure the company's system (policies/ directives) and operation meet and/or exceed current requirements in GXP's (GLP, GCP, PV, GMP) of applicable regulations, rules and guidance.
• Perform audits of clinical trials, vendors, internal processes and pharmacovigilance activities.
• Understand and apply GXP regulatory requirements, industry best practices, and company expectations in resolving audit findings and non-conformances.
• Provide guidance for GLP, GMP and audit to CMO research and manufacturing laboratories.
• Oversee trial quality and ensure compliance with specific clinical plans for all clinical deliverables and identify and mitigate associated risks.
• Maintain oversight of clinical site selection and activation activities. Ensure appropriate tracking throughout including applicable documentation of trial-related information.
• Track and review monitoring visit reports and ensure standards for monitoring and reporting are met; ensure appropriate and timely follow up on open action items
• Work collaboratively with the functional Leader to
• assess current policies and directives to ensure that they meet and/or exceed GxPs, create new/ revised policies and directives as needed, and to eventually standardize processes for continuous improvement
• monitor quality and compliance operational leading and lagging performance indicators across the GXP network to resolve issues and to proactively identify emerging trends to ensure continuous improvement and compliance.
• ensure all clinical trial activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules and guidance.
• coordinate, facilitate and, conduct training for clinical study teams as required. Address ongoing training needs throughout the study and ensure all trial-specific training is documented appropriately

Skills and Requirements:

• Degree in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science). Master or advanced degree is preferred.
• Minimum of 15 years of experience in the biopharmaceutical Industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority.
• Cell therapy experience is highly desirable.
• In-depth working knowledge of GMP, GCP, GLP and FDA and ICH guidelines.
• Experience interacting with US FDA ORA and CBER preferred.
• Experience leading or supporting clinical trial sites and clinical manufacturing sites through global health authority inspections.
• Ability to identify and implement phase-appropriate compliance strategies to support the E2E product lifecycle.
• Demonstrated ability to apply effective risk management approaches. Pragmatic in approach with demonstrated ability to make sound, risk-based decisions.
• Demonstrated ability to work independently and with groups of people/teams in a start-up environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 3159 1467 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

R1215238

EA13C6865