Regulatory Affairs Professional EMEA

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EMEA Regulatory Affairs Solid Tumours is recruiting for a dedicated Regulatory Affairs Professional to work on the development and registration of solid tumour products in Europe the Middle East and Africa (EMEA).

The Regulatory Affairs Professional supports the development registration and lifecycle management of pharmaceutical products within the EMEA region. This role focuses on regulatory tasks such as submission strategies procedural aspects of regulatory affairs and compliance with applicable health authority (HA) regulations project management and would support the EMEA regulatory leader on regulatory product strategy.

The position can be based in the United Kingdom.

This role provides an opportunity to support small and large molecules and in different oncology indications contributing to advancements in healthcare.

The successful applicant will help develop and implement regulatory strategies to achieve efficient development and timely commercialization of innovative pharmaceutical products in compliance with applicable regulations.

General Regulatory Responsibilities

• Guide project teams on regulatory requirements and contribute to regional and local regulatory strategies.
• Support the EMEA Regulatory Leader in developing regulatory strategies for products in product development.
• Assist in submissions to health authorities including CTAs MAAs and lifecycle submissions.
• Contribute to Global Regulatory and cross-functional meetings as the EMEA Regulatory Professional.
• Develop an understanding of the regional regulatory environment therapeutic area and competitor intelligence.
• Draft and review document content based on regulatory knowledge.

Pre-Authorization Activities

Clinical Trial Applications (CTA)

• Review clinical trial protocols to ensure alignment with regulatory requirements.
• Provide guidance on CTA submission strategies and documents such as protocols and Investigators Brochures (IB).
• Coordinate responses to Health Authority Questions (HAQs).

Scientific Advice Orphan Drug Designation and Paediatrics

• Contribute to the development of regulatory submission documents such as briefing documents Paediatric Investigational Plans (PIPs) and Orphan Drug Designations.
• Review response documents to ensure they thoroughly and accurately address regulatory questions.

Authorization Phase (Marketing Authorization Application - MAA)

• Provide regulatory support to the EMEA Regulatory Leader throughout the product lifecycle.
• Guide and collaborate with cross-functional teams on required documents and submission strategies for MAA preparation.
• Identify and supervise critical path activities.
• Assist with timely submission and acceptance of MAA and subsequent procedural steps.
• Ensure country-specific submission packages are made available to Local Operating Companies (LOCs) in accordance with agreed plans.

Lifecycle Activities

• Support lifecycle submissions and post-approval regulatory activities including Variations Post-marketing Commitments and Safety related submissions.
• Maintain oversight of regional lifecycle submissions

Liaison with Regulatory Agencies and Local Operating Companies

• Act as backup for contact with EMA and national Regulatory Agencies
• Support the preparation of meetings with Regulatory Agencies
• Collaborate with LOCs informing regarding product and development status addressing queries as appropriate

Compliance related activities

• Assist in the creation and revision of processes related to regulatory submissions
• Appropriately manage Regulatory Affairs related systems and processes according to regulatory and company standards.

Job Requirements

Education experience and skills

• Bachelors degree (BS) in life sciences medical or paramedical fields (e.g. pharmacy biology veterinary science) or equivalent experience. A Masters degree (MS) MBA or higher qualification is considered a plus.
• Experience in pharmaceutical industry or similar and / or Regulatory Affairs
• 1 or more years of relevant experience capable of working independently on key tasks while escalating higher-complexity issues
• Experience working in cross-functional teams
• Strong oral & written communication skills in English

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Preferred Skills: