Regulatory Affairs Lead
- Employer
- Hyper Recruitment Solutions
- Location
- Wiltshire
- Salary
- Industry Competitive
- Closing date
- 29 Aug 2019
View more
- Sector
- Biotechnology, Regulatory Affairs
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
As the Regulatory Affairs Lead with will take the lead in coordinating, evaluating, preparing and reviewing all the elements required for the application and you will work closely with the Head of Regulatory Affairs and company Managing Director.
This is a fantastic opportunity for a Senior Regulatory professional looking to have full project ownership and to be accountable for a company defining project.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Lead will be varied however the key duties and responsibilities are as follows:
1. Develop submission strategy for an MAA filing to the EMA under EU Centralised Procedures.
2. You will be the Project Lead and will review available data, conduct gap analysis as well as ensuring budgets and timelines maintained.
3. You will work closely with company Senior Executives and company Managing Director as well as Directors across Manufacturing and Quality to ensure successful project delivery.
4. You will work cross-functionally internally as well as being the main point of contact for Regulatory Authority interactions.
5. You will need to be pragmatic in your strategic approach and understand the key strategic regulatory challenges associated with Biologic Pharmaceuticals while also undertaking critical decision-making.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Regulatory Affairs Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences (e.g. Biology, Biochemistry, discipline where understand and experience of Biological product manufacturing and registration is preferable.
2. Proven industry experience in a Regulatory Affairs setting where you have developed submission Strategy to EU markets under Centralised Procedures is vital to your application.
3. Experience of preparing, coordinating and reviewing responses to EU regulatory authorities.
4. Be able to write and critical review technical documents and CTD/eCTD sections.
Key Words: Regulatory Affairs | Senior Manager | MAA | Marketing Authorisation Application | CP | Centralised Procedures | EMA | European Medicines Agency | EU | Strategy | Due Diligence | Regulatory Lead |
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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