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Job Details

Regulatory Affairs Senior Associate

Company: SRG Clinical
Location: Middlesex
Reference: J27522
Closing Date: 03 Aug 18
Type: Part Time
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 Senior Regulatory Affairs Associate on an initial 12 month contract to be based in their offices in Middlesex.


The Role:

The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Key Responsibilities:

* Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing)
* Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
* Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
* Review regional component of the Global Regulatory Plan and provide input to operational deliverables
* Ensure compliance via timely submissions to regulatory agencies and support RRL in review of promotional materials for commercial activities (ex-US)
* Collaborate with CROs / partners to support site initiation and coordinate collection of functional documents in support of regulatory applications
* As appropriate participate in GRT to support execution of regulatory strategy and coordinate QC of regulatory documentation (e.g. briefing packages)
* Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
* Prepare regulatory packages and cross-reference letters to support investigator initiated studies
* Approve drug shipment for Company and Investigator Initiated Studies Complete regulatory forms to support agency communications (E.G. EudraCT,)
* Support process improvement initiatives, standards development, and metrics

Skills/Experience Required:

* Minimum graduate level, in any life sciences.

* EU experience, regional level rather than affiliate level
* Preparing and submitting CTAs applications. It would be a bonus if they have used the VHP.
* Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products.
* 3 years’ experience

If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673

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 Senior 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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