Global Regulatory Lead REF: 1079
We are currently looking for a Global Regulatory Lead to work on an industry-leading Vaccines portfolio for a top 10 Biopharma company.
The location can be US or Belgium to align with the client’s relevant time zones and key stakeholders.
- Responsible for identifying regulatory strategies
- Managing file content, preparing and submitting regulatory files
- Coordinating and submitting responses to RTQs, liaising with regulatory authorities.
- Working closely with Project Manager to track/monitor deliverables.
- Conducting thorough reviews of submission packages (including labeling, RTQs and initial filings) to ensure alignment with company position and agency requirements
This role requires strong knowledge of US regulations (FDA), and previous experience in clinical regulatory and labeling
The ideal candidate will have:
- Experience working in matrixed environment (RA, clinical, CMC, safety, statistics, labeling) in the development and/or life cycle space.
- Ability to hit the ground running with more minimal onboarding; be a self-starter; have the ability to network and problem solve; be a strong communicator (written and spoken)
submit your CV
- Contract Type:
US based, remote working
12 months +
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