EMEA Regulatory Professional

Location Leiden, Gemeente Leiden, South Holland
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Selin Ozbeden

Contact email: s.ozbeden@panda-int.com
Job ref: 13311
Published: 28 days ago

For one of our leading Pharmaceutical clients we are looking for a Regulatory Professional!

EMEA Regulatory Professional

Education and experience
• 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

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

       •  ASAP

       •  12 months (high chance of extension)

If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on   +31 (0)20 20 44 502