Regulatory Affairs Specialist | 32/24 hours per week | Remote work possible

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands.

The Company

For more than 25 years, they have been a leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. Their work has revolutionized the science of immunology. They pioneered monoclonal antibody technology, a cutting-edge approach that launched a new generation of products to treat immune-related diseases.

Role Description

You will work with the EMEA Regulatory Liaison hand in hand with the commercial arm of the EMEA (Europe Middle East and Africa) organization to ensure rapid market access of our products and optimal support of products already on the market. The team also provides regulatory support through the entire product life cycle, by providing regional regulatory strategy, advice, HA communications and support submissions, for EMEA products and EMEA Regulatory activities through development and product life-cycle.

Responsibilities

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
• Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area

Liaison with Regulatory Agencies and Local Operating Companies
• Act as back-up for contact with Regulatory Agencies as needed
• Assist in the preparation of meetings with Regulatory Agencies
• Draft cover letters for Regulatory Agency communication
• 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

Support of Marketing Authorization Applications (MAA) in EMEA region:
• 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

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

Requirements

- University degree in Life Sciences (pharmacy, biology, veterinary etc.), or equivalent by experience;
- Minimal 3 years of relevant Regulatory experience
- International team work experience is a plus

Other information

This position will be for 24 to 32 a week. Remote work possible with a minimal commitment of 1-2 days in Leiden (depending on seniority).

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.