SIRE Life Sciences®

RA Manager

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Noord-Holland Netherlands.

Beautifully located in the dunes, this company develops some of the world’s most unique pharmaceutical products on a grand scale. Since the recent merger they have become the biggest supplier in the world and are therefore looking to expand their RA team.

ROLE DESCRIPTION

The position is answering to the Regulatory Head and will be acting as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy. Externally, the individual will interact with outside regulatory agencies and business partners in regards to development, regulatory, and registration strategies.

RESPONSIBILITIES

• Provides strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies
• Uses extensive knowledge of NL and EU regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
• Able to articulate complex Regulatory issues and support global development and commercialization of early and late state programs
• Oversees and/or leads as necessary the preparation and submission of documentation to support investigational and marketing registration packages throughout Europe and ensures timelines are met
• Maintains awareness of European regulatory environment and assesses impact of changes on business and product development programs.
• Develops and implements department policies, processes and SOPs

REQUIREMENTS

BA/BS Degree required, preferably in a health/life sciences or related field
A minimum of 8 years in the pharmaceutical industry. Experience in CMC Regulatory, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams.
Strong understanding of and experience with global medical device-drug combination regulatory approvals;
Business travel to be ~10-20% as required

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

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SIRE Life Sciences®

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