Are you an experienced Regulatory Affairs professional looking forward to an exciting mission at a global pharmaceutical company?
Then check out this (entirely remote) opportunity. You will be involved in the regional regulatory strategy for products in the client's oncology pipeline.
Job Description
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.
Responsibilities
- 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
- Act as backup 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
- 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
- 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
- Provide regulatory support throughout registration process
- Provide regulatory support throughout life-cycle management
- Advice 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
Requirements
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Experience in regulatory affairs
- Teamwork experience
- Project management skills
- Oral & written communication skills
- Organization & multi-tasking skills
- Knowledge of the regulatory environment, guidelines and practice of EMEA regions
Benefits
- Full-time position
- A balanced salary package based on your capabilities and experience
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 18127
