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First Name*

Last Name*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Officer /Associate

Location: United Kingdom

Proclinical has partnered with a global pharmaceutical organisation in search for a Regulatory Affairs Senior Associate. The Regulatory Affairs Senior Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects.

Job Responsibilities

Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission)
Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
Coordinate collection of functional documents in support of regulatory applications
Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications
As appropriate may participate in GRT to support execution of regulatory strategy
Respond to specific requests from and communicate relevant issues to GRT
Support the development and execution of GRT goals
Review regional component of the Global Regulatory Plan and provide input to operational deliverables
May support RRL in review of promotional materials for commercial activities
Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
Support process improvement initiatives, standards development, and metrics

Skills and Requirements

Graduate in a life science subject as a minimum, post graduate degree desirable
Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred
Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products including orphan indications
Keeps up to date with professional knowledge, expertise and best practice.
Excellent oral and written communication skills.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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