Regulatory Affairs Operations Manager
- Employer
- Hyper Recruitment Solutions
- Location
- Hertfordshire
- Salary
- Industry Competitive
- Closing date
- 17 Sep 2019
View more
- Sector
- Pharmaceutical, Publishing, Regulatory Affairs
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
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 RESPONSIBILITIES:
Your 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 REQUIREMENTS:
To 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
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
Company
Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.
Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.
Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.
We provide services across a broad range of industries including the following specialist sectors:
• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science
With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:
• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments
HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.
Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com
Or any of the social media routes below:
Twitter
Facebook
Linked in
Google +
- Website
- http://www.hyperec.com/
- Telephone
- 0203 910 2980
- Location
-
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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