Senior Director Regulatory Affairs
Location: BelgiumSIRE 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 Biotechnology and Pharmaceutical organization, based in Brussel Belgium.
They grasp innovation to advance the health and well-being of people around the world.
ROLE DESCRIPTION
The Senior Director Regulatory Affairs will be responsible for leading activities of Regulatory Affairs with an emphasis on global regulatory strategy and the preparation, review and submission of documents to the FDA and other regulatory authorities. This position will be key in collaborations with the clients partners for the development of new pharmaceutical products.
RESPONSIBILITIES
- Oversee implementation of regulatory strategy and activities needed to secure approval of new drugs.
- Formulate regulatory strategies based on current regulatory intelligence.
- Manage the coordination, preparation and timely submission of regulatory documents.
- Maintain current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required).
- Serve as a principal interface with reviewers from FDA and other health authorities.
- Identify gaps in product development plans that may pose regulatory issues.
- Maintain and build collaborative relationships with partners to improve effectiveness in regulatory.
- Develop and maintains cooperative relationships with external vendors and regulatory health authorities.
- Coordinate activities for meetings with FDA, EMEA, and other regulatory authorities.
- Supervises employees, consultants/contractors in Regulatory Affairs.
REQUIREMENTS
- Advanced degree MD, Pharm.D. or Ph.D. in Life Science,
- 10+ years of drug development and regulatory affairs experience in the Biotech/Pharmaceutical industry.
- Staten experience with interpreting and stay current with FDA, EMA and other regulatory agency regulations and guidelines.
- Experience with eCTD requirements and electronic submissions.
- Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory.
- Demonstrated leadership skills.
- Ability to work effectively across teams, functions and with outside partners.
- Excellent oral and written communication skills.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
