Senior regulatory Affairs Manager - Early phase
Om jobbet
PharmaRelations is the Nordic Market Leader within Talent services for the Life Science industry. We specialize in partnering with some of the top and most innovative organizations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
We are a Nordic organization with over 200 colleagues and with offices in Sweden, Norway, Denmark and Finland. Our headquarter is in Solna, Sweden.
About the Role:
We are looking for a flexible and experienced professional to join our team of consultants asSenior Regulatory Manager (CMC)- early phase.
This assignment will be placed at one of our valued clients, a global pharmaceutical company, in Stockholm. The company is in a very exciting phase, so personal fit as well as professional skills are of importance. We believe you have strong verbal and written skills in English and have residency in, preferably, greater Stockholm area.
What you will do:
Plan and deliver CMC documents according to timelines for applications of clinical trials.
Handle contacts with CA and participate in CA meetings.
Take part in the development of regulatory strategies for company product candidates; early phase, pre submission and post marketing.
Lead Regulatory CMC meetings for applicable product candidates.
Participate and represent Regulatory in project meetings with external support e.g., CRO, CMO, Regulatory consultants as applicable.
Write and update Standard Operating Procedures (SOP) for Regulatory procedures and other regulatory process related documents.
Review other quality related document including SOPs, specifications and other CMC reports from a regulatory perspective.
Mandate for signing
Approve Regulatory CMC documents and applications to CA.
As author, signing of SOPs and other process related documents within Regulatory Affairs.
Apply today!
If you have the expertise, right personal fit, and drive to excel in this role, we would love to hear from you!
For further information please don't hesitate to reach out to Consultant Manager shiva.nowzari@pharmarelations.se, +46701652264.
Please send in your application as soon as possible, as interviews are being conducted on a continuous basis. We look forward to hearing from you!
Due to GDPR, we cannot receive any CVs via e-mail. Please apply via the link below.
We are a Nordic organization with over 200 colleagues and with offices in Sweden, Norway, Denmark and Finland. Our headquarter is in Solna, Sweden.
About the Role:
We are looking for a flexible and experienced professional to join our team of consultants asSenior Regulatory Manager (CMC)- early phase.
This assignment will be placed at one of our valued clients, a global pharmaceutical company, in Stockholm. The company is in a very exciting phase, so personal fit as well as professional skills are of importance. We believe you have strong verbal and written skills in English and have residency in, preferably, greater Stockholm area.
What you will do:
- Responsible for coordinating the preparation of CMC dossier documents for submission of Marketing Authorisation applications and post-approval changes to Competent Authorities (CA).
- Responsible for advice, creation and review of CMC dossier documents for submission to CA.
Plan and deliver CMC documents according to timelines for applications of clinical trials.
Handle contacts with CA and participate in CA meetings.
Take part in the development of regulatory strategies for company product candidates; early phase, pre submission and post marketing.
Lead Regulatory CMC meetings for applicable product candidates.
Participate and represent Regulatory in project meetings with external support e.g., CRO, CMO, Regulatory consultants as applicable.
Write and update Standard Operating Procedures (SOP) for Regulatory procedures and other regulatory process related documents.
Review other quality related document including SOPs, specifications and other CMC reports from a regulatory perspective.
Mandate for signing
Approve Regulatory CMC documents and applications to CA.
As author, signing of SOPs and other process related documents within Regulatory Affairs.
Apply today!
If you have the expertise, right personal fit, and drive to excel in this role, we would love to hear from you!
For further information please don't hesitate to reach out to Consultant Manager shiva.nowzari@pharmarelations.se, +46701652264.
Please send in your application as soon as possible, as interviews are being conducted on a continuous basis. We look forward to hearing from you!
Due to GDPR, we cannot receive any CVs via e-mail. Please apply via the link below.
PharmaRelations AB
FöretagPharmaRelations AB
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