Senior Associate Regulatory Affairs

Location:
Middlesex
Sector:
Administration
Job Type:
Temporary
Salary range:
Other
Salary:
£45,760 to £45,760 per annum
Salary:
£22 per hour
Posted:
01-Aug-18
Start Date:
Recruiter:
Uxbridge Employment Agency
Job Ref:
888405

Leader in their industry requires a Senior Associate Regulatory Affairs based in Uxbridge

• Assist in the creation and submission of regulatory documents

• Assist Regional Regulatory Lead to support regional regulatory pre-filing activities

• Provide and maintain documentation support

• Review regional component of the Global Regulatory Plan and provide input to operational deliverables

• Ensure compliance via timely submissions to regulatory agencies

• Support RRL in review of promotional materials for commercial activities

• Collaborate with partners to support site initiation

• Coordinate collection of functional documents in support of regulatory applications As appropriate

• Provide primary authorship to routine regulatory correspondence

• 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

• Provide regulatory support to Commercial, Medical and Clinical departments

• Support process improvement initiatives, standards development, and metrics

• Assist in template development and maintenance

• Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams

• Actively support regulatory compliance

Key Skills

• Strong communication skills - oral and written

• Organizational skills Understanding of drug development process

• EU experience, regional level rather than affiliate level

• Preparing and submitting CTAs applications

• It would be an advantage if used the VHP

• Coordinating response preparation.

• Must have a scientific background

• Some familiarity with regulatory guidelines.

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We are an independent recruitment agency who are celebrating our 40th year of supporting local candidates find local opportunities. Based centrally in both Uxbridge & Windsor we offer permanent, temporary and contract recruitment services within Middlesex, Buckinghamshire, Berkshire and the West London region.

For the purpose of the Conduct Regulations please be advised that when advertising permanent vacancies we are acting as an Employment Agency and when advertising temporary/contract vacancies we are acting as an Employment Business.

We take your personal data seriously and take every step to protect it. To learn how we handle your data please visit our website where you can find our Data Privacy Notice.

Contact Details:
Uxbridge Employment Agency
Tel: 01895 520 700
Contact: Orla Walker
Email:

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