Job Description Regulatory Affairs Project Manager
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JOB SUMMARY:
i-Pharm Regulatory’s client, a leading biopharmaceutical company, is searching for a Regulatory Affairs Project Manager to co-ordinate, prioritise and track regulatory activities. This exciting opportunity will give exposure to many aspects of Regulatory and have you dealing with several teams and departments.
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RESPONSIBILITIES

i-Pharm Regulatory have a Regulatory Affairs Project manager position for an experienced professional with full lifecycle experience. The successful applicant will be managing the submissions process and not handling it themselves, however experience of performing submissions is necessary.

• Develop and maintain detailed timelines for regional regulatory activities and submissions for assigned therapeutic areas
• Will communicate with several Regulatory Affairs groups (CMC groups, regulatory leads, Labelling and advertising etc)
• Ensure submissions fall within ICH requirements as well as other local and regional regulatory requirements.
• Responsible for the tracking of regulatory commitments and timelines for activities such as: Annual reports, License Renewals, Post marketing Commitments etc.

Ideally you will come from around 5 years regulatory affairs experience and have exceptional verbal and written skills as well as outstanding negotiation, interpersonal and communication skills.
Will need a well-rounded knowledge of Regulatory affairs within the EU and UK affiliates.

This position will allow the successful candidate to take a step up in their career and take a step into a well respected and admired Biotech company.

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TO APPLY

If you would like to discuss this vacancy further, please call i-Pharm Regulatory Team Leader Joe Balfour on +44 (0)20 3189 2299, or email jbalfour@i-pharmconsulting.com. If this role is not suitable, Joe is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


ABOUT i-PHARM REGULATORY


i-Pharm Regulatory is a specialist Recruitment team working wholly within the Regulatory Affairs market. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). I-Pharm Regulatory is a team within the larger organisation i-Pharm consulting which provides candidates in areas such as: Clinical Operations, Pharmacovigilance, Biometrics, Project Managements, Quality Assurance and Health Economics. Visit our website to see our extensive current vacancies:

www.i-pharmconsulting.com




KEY WORDS

Regulatory affairs, senior regulatory affairs executive, senior regulatory affairs, clinical regulatory affairs, reg affairs, regulatory affairs manager, regulatory affairs senior manager, regulatory affairs director, development, regulatory affairs manager, regulatory intelligence, Cambridge, Hertforshire