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Job Details

Regulatory Affairs Associate

Company: SRG Clinical
Location: Cambridge
Reference: J25257
Closing Date: 28 Feb 18
Type: Permanent
Salary (£): Negotiable

Job Summary:

My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Associate- to be based at their offices in Cambridge.


The Role:

Working within Global Regulatory Affairs you will be responsible for submitting regulatory submissions as well as working on obtaining approval of regulatory submissions through interactive communication with Global Health Authorities for investigational and/or marketed drug products.


* Review and prepare routine regulatory submissions (e.g., investigator submissions, correspondence to Health Authorities, etc.) as well as supports senior-level staff in the preparation, QC, and submissions of major submissions (initial CTAs/INDs, MAAs/NDAs, Orphan Drug designations, PIPs, variations, and supplements) for investigational and/or marketed drug products.
* Maintain trackers and electronic files.
* Develop initial draft and work with Supervisor to develop regulatory strategy on preclinical, clinical and/or CMC issues
* Regulatory Intelligence (research regulations, guidance, precedence) responsibilities as assigned by Supervisor.
* Coordinate and support the team in planning and preparation for Health Authority meetings or teleconference.

Experience / Qualifications:

* PharmD, B.Sc. or Master’s degree qualified
* Industry experience within Regulatory Affairs experience in new drug regulated product strategy and submissions; including working knowledge of Health Authority regulations and guidance for new drugs.
* Strong understanding of regulations/guidelines governing development of pharmaceuticals.
* Able to challenge the status quo to achieve continuous improvement.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Apply for this job: Regulatory Affairs Associate

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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