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GE HealthCare Associated Director Regulatory Affairs CMC Remote, Remote 505395640
Yesterday
The position is hybrid or fully remote.
Roles and Responsibilities
- To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products
- Build, or provide input to, submission strategy documents by defining variation type, data required to support submission, and submission documents required for the submission package. Review and approve published output.
- Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
- Prepare and maintain CMC sections of global regulatory submissions, including INDs, IMPDs, NDAs, MAAs, variations, and supplements
- Provide consistent expert advice to the organisation, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues
- To direct, manage and review outsourced regulatory CMC related regulatory activities for the assigned projects/products.
- Maintain registration tracking information and assist in the development of good document management practice standards.
- Interact with regulatory agencies during scientific advice, pre-approval inspections, and post-approval queries
- To support QA during audits and inspections as required.
Required Qualifications
- Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (Doctor of Pharmacy (PharmD) or MSc in Radiopharmacy preferred)
- Minimum 3 years of experience in Regulatory Affairs (CMC focus), with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals
- Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds
Desired Characteristics
- Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters)
- Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry
- Experience of regulatory project management and regulatory agency interactions
- Experience with Veeva RIM or other registration tracking tools.
- Ability to work across cultures/countries/sites.
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