Regulatory Manager – Oncology
G&L Scientific are looking for additional talent for our US team. We are looking for dynamic and flexible individuals who have a consultative approach to their work. We work with a broad selection of pharmaceutical, biotechnology and device clients across the globe and each project can vary significantly.
We have an opening for a Senior Regulatory Affairs professional, with previous working experience in oncology and CV products.
Duties will include:
- Responsibility for developing and implementing the global regulatory strategy to support the development and delivery of drug products to enhance the value of our pharmaceutical products across therapeutic areas.
- Provide regulatory support and guidance to Global Regulatory Leads (GRTLs), development teams, commercial and/or project drug/diagnostic subteams on the regulatory strategy and execution of the integrated drug development plan.
- Ensure global regulatory plans support an approach (ie integrated drug/ regulatory and submission plans), including HA engagement plans and mitigation strategies.
- Support the preparation of health authority documents and governance presentations containing precision medicine plans.
- Ensure consistent positions are presented in responses to global health authority (HA) queries.
- Propose innovative approaches to resolve complex regulatory issues and increase speed to patients.
- Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products.
All our staff are encouraged to have the confidence to speak their mind and suggest new ideas. All our consultants are expected to act as mentors to junior staff, contributing to the development of graduate and junior training programs.
Above all, our company is all about our people so you should have a passion for meritocracy, recognition, and development.
We hope that you will feel excited about making suggestions or challenging existing methodologies. G&L’s reputation has been built on our customer service and client-focus so any ideas that will help us stay ahead of the curve are encouraged.
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- Contract Type:
US Based, remote working
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