J3538CambridgeshirePharmaceutical PermanentDependent on experienceFull Time09/02/2017Regulatory Affairs
Regulatory Affairs – UK
Regulatory Affairs – EU
Regulatory Affairs – Global
Regulatory Affairs – Clinical
Regulatory Affairs - CMC
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Hyper Recruitment Solutions are currently looking for a Principal Regulatory Consultant to join a leading life sciences company based in the Cambridgeshire area. As the Principal Regulatory Consultant you will be responsible for providing regulatory consultancy services to a wide variety of internal and external customers, including preparation, review, submission and project management of regulatory applications.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Principal Regulatory Consultant will be varied however the key duties and responsibilities are as follows:
1. You will provide up to date regulatory advise to internal and external clients as required.
2. As the Principal Regulatory Consultant you will prepare, review, submit and project manage regulatory submissions in compliance with the applicable SOPs, regulatory guidelines and legislation.
3. You will participate in business development activities as required and input in to monthly invoicing and maintain financial control of assigned projects.
4. As the Principal Regulatory Consultant you will participate in/present at internal and external training courses and conferences as required.
To be successful in your application to this exciting opportunity as the Principal Regulatory Consultant we are looking to identify the following on your profile and past history:
1. Relevant Science degree.
2. Proven regulatory affairs experience across CMC/biotech, clinical with EU and US market interactions.
3. Early stage to post marketing project management experience.
Key Words: regulatory affairs, submissions, business development, strategy, training, CMC, biotech, pharmaceuticals, clinical, post marketing
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant 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 scientists supporting science. We look forward to helping you with your next career moves.