Pharmaceutical Consultant
Vor 3 Tagen
Our client, a Swiss pharmaceutical company, is seeking a highly skilled Pharmaceutical Consultant to lead the update and submission of major regulatory dossiers.
Key Responsibilities:- Update and submit major regulatory dossiers, ensuring compliance with regulatory standards.
- Extract, interpret, and integrate clinical data from several study reports.
- Collaborate with medical writers to develop summary of safety, clinical overview, and other key documentation.
- Evaluate long-term safety data and incorporate findings into updated submissions.
- Act as the lead for clinical submissions, addressing challenges in dossier structure and improving document quality.
- Partner with internal and external teams to align on submission strategies and timelines.
- Advanced degree in life sciences, medicine, or a related field.
- At least 8 years of experience in regulatory affairs, clinical science, or related roles, with a focus on dossier preparation and submissions.
- Proven track record of leading NDA and MAA submissions in the pharmaceutical/biotech industry.
- Ability to navigate and improve poorly structured dossiers with a critical, problem-solving mindset.
- Strong analytical, data interpretation, and regulatory writing skills.
- Excellent communication and leadership skills, guiding cross-functional teams.
This is a unique opportunity to work with a company that is committed to making a difference in the lives of patients.
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