Job Description
PE Global is currently recruiting for a Senior Associate Regulatory Affairs for a leading multi-national Pharma client based in Cambridge.
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This is an initial 12 months contract position with potential for extension.
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Pay rate is £*****ph PAYE or £*****ph Umbrella.
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Working mainly from home but would be expected to go in for team meetings (once a month in Cambridge).
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The Senior Associate Regulatory Affairs is assigned to one or more company products and may support an LRR or lead the planning and execution of Regulatory strategies for a program(s) under the supervision of an experienced Regulatory Lead.
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Duties of the
role/Responsibilities
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Assist in aligning local regulatory requirements with company's corporate standards.
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Provide national/regional (as applicable) input to and execute regulatory strategies.
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Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
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Provide guidance on local mechanisms to optimize product development and regulatory approvals
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Ensure local labels are developed and maintained in line with local legislation and company standards and procedures.
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Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)
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Act as the point of contact with regulatory agencies.
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Ensures regulatory submissions are made on time and meet company's corporate and local regulatory requirements.
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Creates, reviews, and approves source text for country labeling, and owns the country artwork based on source text.
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Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
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Reviews and approves the promotional and non-promotional materials
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Monitors the external regulatory workplace to help inform/advise in the regulatory decision making.
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Education/Experience
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Master's degree (scientific area) OR
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Bachelor's degree (scientific area) and 2 years of directly related experience
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Knowledge of Regulatory principles.
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Working with policies, procedures and SOP's.
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Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
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General knowledge of national legislation and regulations relating to medicinal products.
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Understanding of drug development.
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Ability to understand and communicate
scientific/clinical
information.
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***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

📌 Senior Regulatory Affairs Associate (Hobart)
🏢 PE Global (UK)
📍 Hobart