Scientific Integrator (Regulatory CMC Dossier Development) - Belgium
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- We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
- Employees of our company work with partners in health care to touch the lives of over a billion people every day, throughout the world.
- Our company is one of the most innovative pharmaceutical companies in the world.
- Our research and development center develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
- The Dossier Development & Operations Department, which is part of the Pharmaceutical Development & Manufacturing Sciences group, is responsible for the authoring of all CMC regulatory dossiers for our company.
- The Scientific Integrator Dossier Development is responsible for authoring the regulatory CMC dossiers.
- He/she provides input and scientific oversight to the generation of the Quality modules 2 and 3 of marketing and clinical trial applications.
- He/she represents the department on 3-5 multi-functional CMC teams to support regulatory filings for innovative medicinal products.
- He/she must possess scientific understanding of pharmaceutical development as well as knowledge of the proper interpretation of applicable global regulatory guidelines. He/she assumes personal ownership and accountability for business results and solutions; consistently delivers results; makes the customer’s needs a central point of focus with minimal supervision.
- He/she authors/drives the Module 2 and 3 Quality sections and evaluates/ensures that final versions comply with regulatory requirements and fulfill Regulatory Agency expectations.
- He/she authors global marketing authorization submissions, clinical trial submissions, and responses to health authority questions.
- Proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed.
- He/she demonstrates focus and clarity of thought under ambiguous or complex situations with minimal supervision.
- He/she provides interpretation of relevant CMC guidelines (ICH, FDA, EMA, etc.) and provides prompt regulatory risk assessments and recommendations.
- He/she mentors others in regulatory guidance.
- The requirements are dependent of the level (scientist/ senior scientist/ associate director):
- A Master’s degree or PhD in a life science (organic chemistry, pharmacy, biochemistry…) is required.
- Knowledge of both large molecule and small molecule pharmaceutical CMC development is desired.
- Some years of relevant industry experience (chemical development, pharmaceutical development, analytical development, post-doctoral, graduate course work, etc....) is preferred. CMC regulatory dossier authoring experience in a Regulatory Affairs or Dossier Development group is a plus.
- The candidate should possess the requisite people management and negotiating skills for managing the authoring process of marketing authorization applications. Proficiency in commonly used computer applications including WORD, EXCEL etc. is required.
- Excellent verbal and written English language skills are required.
This position requires up to 10% international travel.
- As an employee we consider you as our most valuable asset. We take your career seriously.
- As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
- Through e-university, on the job training, various projects and programs, we ensure your personal growth.
- Our benefits make sure we care for you and your family now and in the future.