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- Aufgaben: Lead the update and submission of major regulatory dossiers for a Swiss pharma company.
- Arbeitgeber: Join a leading Swiss pharmaceutical firm focused on innovative medicines for rare diseases.
- Mitarbeitervorteile: Full-time contract with potential for extension; work in a dynamic, impactful environment.
- Warum dieser Job: Make a real difference in patient care while enhancing your expertise in regulatory affairs.
- Gewünschte Qualifikationen: Advanced degree in life sciences and 8+ years in regulatory affairs required.
- Andere Informationen: Must be eligible to work in Switzerland and the EU.
Das voraussichtliche Gehalt liegt zwischen 72000 - 84000 € pro Jahr.
Clinical Dossier Lead Consultant
Location: Basel
Contract: 6-month, with potential for extension
Start Date: ASAP
Workload: Full-time
Overview: Our client, a Swiss pharmaceutical company specializing in medicines for rare diseases, is seeking an experienced Clinical Dossier Lead Consultant. This role involves leading the update and submission of major regulatory dossiers.
Key Responsibilities:
- Lead the update of major regulatory dossiers.
- Extract, interpret, and integrate clinical data from several study reports, ensuring consistency and accuracy.
- Collaborate with and provide direction to medical writers for summary of safety, clinical overview, and other key documentation.
- Evaluate long-term safety data for an already submitted dossier and incorporate findings into updated submissions.
- Act as the lead for clinical submissions, ensuring compliance with regulatory standards for NDA and MAA filings.
- Address challenges in the existing dossier structure and improve document quality for clarity and coherence.
- Partner with internal and external teams to align on submission strategies and timelines.
Required Qualifications:
- Advanced degree in life sciences, medicine, or a related field.
- Extensive experience (8+ years) 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, with experience guiding cross-functional teams.
Please apply directly online with your CV and only apply if you are eligible to work in Switzerland and the EU .
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Clinical Dossier Lead Consultant Arbeitgeber: PharmiWeb.jobs: Global Life Science Jobs
Kontaktperson:
PharmiWeb.jobs: Global Life Science Jobs HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Clinical Dossier Lead Consultant
✨Tip Number 1
Make sure to highlight your extensive experience in regulatory affairs and dossier preparation during the interview. Be ready to discuss specific examples of NDA and MAA submissions you've led, as this will demonstrate your expertise and suitability for the role.
✨Tip Number 2
Familiarize yourself with the latest regulatory standards and guidelines relevant to clinical submissions. This knowledge will not only help you answer questions confidently but also show your commitment to staying updated in the field.
✨Tip Number 3
Prepare to discuss your problem-solving approach when it comes to improving poorly structured dossiers. Think of specific challenges you've faced in the past and how you successfully navigated them, as this will showcase your critical thinking skills.
✨Tip Number 4
Since collaboration is key in this role, be ready to share examples of how you've effectively partnered with cross-functional teams. Highlight your communication and leadership skills to demonstrate that you can guide teams towards successful submission strategies.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Clinical Dossier Lead Consultant
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly read the job description for the Clinical Dossier Lead Consultant position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your extensive experience in regulatory affairs and dossier preparation. Provide specific examples of your work with NDA and MAA submissions to demonstrate your expertise.
Showcase Leadership Skills: Since the role requires strong leadership and communication skills, include examples of how you've successfully guided cross-functional teams in previous roles. This will help illustrate your capability to lead in this position.
Tailor Your Application: Customize your CV and cover letter to reflect the specific requirements mentioned in the job description. Use keywords from the listing to ensure your application stands out and aligns with what the company is looking for.
Wie du dich auf ein Vorstellungsgespräch bei PharmiWeb.jobs: Global Life Science Jobs vorbereitest
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience in regulatory affairs, especially your involvement in NDA and MAA submissions. Highlight specific examples where you led the update and submission of major regulatory dossiers.
✨Demonstrate Analytical Skills
Since the role requires strong analytical and data interpretation skills, be ready to explain how you've extracted and integrated clinical data from study reports in past projects. Use concrete examples to illustrate your problem-solving mindset.
✨Communicate Effectively
Excellent communication is key for this position. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory concepts. Be prepared to showcase your leadership skills in guiding cross-functional teams.
✨Prepare for Dossier Challenges
Anticipate questions about how you would address challenges in existing dossier structures. Think of specific instances where you improved document quality for clarity and coherence, and be ready to share your strategies.
