Job Reference: J5632022
Updated On: 20/08/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Regulatory Affairs Operations Manager to join a leading Biopharmaceutical company based in the Hertfordshire area. As the Regulatory Affairs Operations Manager you will be responsible for the planning, creation and despatch of high-Quality eCTD dossiers.
You will also have the opportunity to use your years of experience to update and change the company's current processes including but not limited to software solutions, updating SOP's, changing of vendors and internal databases.
This is a fantastic opportunity for an experienced Regulatory Affairs Operation Manage to be hands on and take ownership of the changing of company process to ensure the timely and successful submission of life changing Regulatory documentation.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Operations Manager will be varied however the key duties and responsibilities are as follows:
1. You will ensure the compliance of CTD, eCTD and NeeS dossiers to National, US / FDA (BLA) and EU / EMA (MAA) health authorities. You will be charged with ensuring that the company becomes fully electronic and use your knowledge of software and systems to find the appropriate solution.
2. Generate and maintain SOPs and manuals for the Regulatory Affairs department and train staff as required as well as ensuring compliance to Regulatory Standards such as CDISC, EVPRM, eCTD and SPL.
3. Implement new regulatory systems, tools and databases while advising senior members of staff on the advantages of outsourcing or in-sourcing solutions.
4. In this position you would work closely with the Publishing Manager and report into the Regulatory Affairs Compliance Senior Manager and have the opportunity evolve the publishing systems as well as gain hands on experience.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Operations Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline would be beneficial but not essential to your application. Extensive Regulatory Affairs electronic filing experience to both the EMA in the form of MAAs and FDA in the form of BLAs is vital as well as good knowledge of all regulatory application procedures (e.g. IND, CTA, PSUR, NDA and EU procedures - CP, MRP, DCP)
2. Proven experience of system integration and understanding of GxP system validation will be of benefit.
3. A working knowledge of emerging requirements including SLP, RIM xEVMPD and ISO IDMP will help support your application.
Key Words: Regulatory Affairs | Operations Manager | Systems Manager | Publishing | CTD | eCTD | NeeS | FDA | EMA | US | EU | MAA | BLA | CDISC | EVPRM | RIM | IDMP | SLP | GxP | System integration | Submissions | System Validation
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