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)
Award winner of:
International Recruitment Company of the Year by Recruitment International 2016
Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
Best Overseas Operation by Global Recruiters 2017
Highly Commended for Best Large Recruitment Business 2017