Job Description

Regulatory Affairs Senior Manager

UK – home based

12 month contract

37.5 hours per week

Competitive pay rate

Description

• May manage one or more regional leads or support roles Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications)
• Leads development of regional regulatory documents and meetings in accordance with strategy
• Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan)
• Agency interaction

Knowledge and Skills

• 7+ years of experience in Regulatory Affairs concerning CTAs, MAs, post approval changes, extensions and renewals.
• Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Experience with Oncology products in Regulatory Affairs

Applicants must be based in the UK already to be considered for this role

PharmiWeb.jobs

Job Categories: Marketing manager. Job Types: Contract. Salaries: 40,000 - 60,000 and 60,000 - 80,000.

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