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Senior Regulatory Manager

Achieva Group Ltd
Closing date
25 May 2022

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Contract Type
Full Time
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Summary of current position to be filled: A regulatory affairs professional who can support the regional regulatory strategy for products in the oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations.

Job Requirements Education and experience

University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
Experience in regulatory affairs
Teamwork experienceSkills

Project management skills
Oral & written communication skills
Organization & multi-tasking skillsKnowledge

Knowledge of the regulatory environment, guidelines and practice of EMEA regions

Job Description
Input in development, post-approval and Life cycle management
Participate in global regulatory team meetings as appropriate
Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic area
Liaison with Regulatory Agencies and Local Operating Companies
Act as back-up for contact with Regulatory Agencies as needed
Draft cover letters for Regulatory Agency communication
Assist in the preparation of meetings with Regulatory Agencies
Liaise with LOCs, track and respond to queries in a timely manner
Input in document and process development
Assist in development of processes related to regulatory submissions
Draft and review some document content (depending on level of regulatory knowledge / expertise)
Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
Track dates of submissions and Regulatory Agency responses
Clinical Trial Applications (CTA)· Review protocols and ensure alignment with regulatory requirements
· Advise team on required documents and submission strategies in preparation of CTAs
Ensure CTA submission packages are complete and available according to agreed timelines
Review and approve clinical trial supply plans
Marketing Authorization Applications (MAA)· Provide regulatory support throughout registration process
· Provide regulatory support throughout life-cycle management
· Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
Assist with submission and acceptance of MAA· Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
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