Regulatory Compliance Director
- Job type Permanent
- Salary competitive
- Location Singapore, Singapore
- Sector Regulatory Affairs (RA)
Director, Regulatory Compliance
- Perform audits of clinical trials, vendors, internal processes and pharmacovigilance activities.
- Understand and apply regulatory requirements in resolving audit findings and non-conformance.
- Provide guidance for manufacturing and research
- Support quality and ensure compliance with specific clinical plans for all clinical projects
- Oversee clinical site selection and activation activities and ensure appropriate trackingWork collaboratively with the functional Leader to lead through influence and working in cross functional / matrix teams to investigate and manage quality and compliance related issues.
- Proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure continuous improvement and to ensure compliance now and in the future.
- Assist when required in the preparation and management of global regulatory inspections.
- Able to provide written responses to regulatory inspectional observations and/or health authority reports as per requested
- Work with Global Regulatory Affairs and Compliance network to formulate new approaches a Compliance Excellence.
- Stay updated with regulatory landscape
- Degree in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science).
- 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.
- Good knowledge of GMP, GCP, GLP and FDA and ICH guidelines.
- Experience with US FDA ORA and CBER preferred.
- Experience with clinical trial sites and clinical manufacturing sites through global health authority inspections.
- Able to make approach based on risk decision
- Good team player
To apply, please email CV to v.tan(a)realstaffing.com, or call +65 6871 4700 for further information.
Registration No: R1873695
EA License No: 16S8216
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
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International Recruitment Company of the Year by Recruitment International 2016
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