We are looking for a Senior Manager to Head up the Pharmacovigilance and Regulatory Affairs department in the US for one of our most loyal partners. Our partner is a Well-Established Life Science services company which was founded in Europe with a strong international expansion in the US.
The objective of the role is to lead US-Based projects in the Pharmacovigilance and Regulatory Department, providing Regulatory expertise and customer guidance. if you are an ambitious and driven individual with Leadership skills who is keen to build out and lead departments and business units in the future, then I would take 5 minutes to read the jobdescription below :
Key Responsibilities :
- Manage day-to-day PV & RA activities to ensure compliance with regulatory obligations and requests
- Provide advice on US FDA regulatory strategy and requirements for investigational and marketed products to customers.
- Provide regulatory advice in support of global clinical study programmes.
- Lead/participate in specific projects as directed by the Senior Management
- Participate in client meetings and liaise with clients regarding ongoing projects.
- Prepare, coordinate and review documents in order to support regulatory submissions for both investigational and commercial products, including safety submissions.
- Liaise with the FDA including the organisation of agency meetings and associated briefing materials,
- Ensure compliance with US regulatory requirements
- Manage and support, pharmacovigilance case management activities (SAE case entry, regulatory assessment of SAEs and submissions)
- Preparation, coordination and review of key PV related regulatory documents for both investigational and marketed products (DSUR, PSUR, and RMP.)
- Co-ordination and execution of on-going pharmacovigilance activities such as literature review, signal detection, project steering committee meetings, management of labelling documents.
- Internal Recruitment of the PV and RA team and Day-2-Day Management
- Support Senior Management and participate in Business Development Activities
- Communicate ideas, highlighting issues of importance and providing solutions to potential problems.
- Create and review relevant Regulatory Affairs and/or Medical Affairs documentation.
You have 5-10 Years experience working in Clinical Research with experience in running Projects and Studies in Smaller and Medium Sized Biotechs.
You have solid knowledge and understanding of US PV and RA legislation and procedures, any additional regional knowledge is a definite plus.
You have experience in writing technical and scientific documents across the full product lifecycle. Strong Technical Knowledge is an advantage (CMC/NCx/R&D/Cx)
You are a detailed and Quality oriented person who is able to run multiple projects in an efficient and agile way.
You have a do-mentality and you are a future leader who is eager to taken on bigger and more complex responsibilities in a fast growing organisation.
If you want more information about this role, please send us an email Olivier@xplorepharma.com or Gary@xplorepharma.com