Senior Regulatory Specialist
- Provide regulatory support to the site for products of responsibility
- Support the plan and execution of regulatory strategies and priorities through effective partnerships with the site and global CMC product responsible scientists.
- Maintain working knowledge of current and emerging government and worldwide requirements for initial registration, re-registrations and post approval changes. and evaluate impact to the site
- Assure that filed information on current approved dossiers is kept updated.
- Provide Regulatory support, guidance and advice, in terms of supportive data for filings
- Review site technical reports when complete from Regulatory perspective -
- Provide training to the site personnel regarding product registration requirements and applicable regulations and guidelines
- Provide Regulatory support as required during HA inspections
- Leverage off the global network in terms of Regulatory guidance and support for small molecules when required.
- Review site change control to provide pre-read on impact to Clinical / commercial licences for proposed changes
- Co-ordination of Health registration requests
- Degree in chemistry, chemical engineering, pharmacy, biological sciences or related discipline.
- Min 5 Years' experience In the pharmaceutical industry -- Regulatory experience in research, development and / or manufacturing
- 3 years regulatory / QA experience required in the pharmaceutical industry
- Direct Experience with regulatory submissions desirable
- Proven ability to effectively influence site and global personnel
- Strong knowledge of regulatory and compliance guidelines within the pharmaceutical manufacturing
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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