EMEA Regulatory Compliance Manager

  • Location: BEERSE
  • Type: Contracting
  • Job #16944

 Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

 

EMEA Regulatory Compliance Manager

Department: Global Regulatory Affairs

Reports to: EMEA Regulatory Liaison or EMEA Regional Therapeutic Area Leader

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 Description

1. 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

2. 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

3. 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

4. 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

5. 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

1. Job Requirements

Education and experience
• University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
• Experience in regulatory affairs
• Teamwork experience

Skills
• Project management skills
• Oral & written communication skills
• Organization & multi-tasking skills

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

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Are you interested? Apply now with your cv!

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