- Our company is one of the most innovative pharmaceutical companies in the world and employs more than 4,000 professionals in Belgium.
- 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.
- Our company is recruiting for a Manager, CMC Regulatory Affairs, to be located in Belgium.
- Our company develops treatments that improve the health and lifestyles of people worldwide. R&D areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
- You will provide strategic global regulatory advice within Regulatory Affairs and research and manufacturing organizations specific to the area of Chemistry, Manufacturing and Control (CMC). The primary responsibility is to support pre- and post-approval products.
- You will also interact as necessary with the CMC Team, cross-functional technical teams, local operating companies, other business partners and outside consultants.
- The strategic regulatory advice includes the interpretation and application of global CMC regulations and guidance within the context of each project’s boundaries.
- You ensure the appropriate CMC activities occur in support of the timely submissions and provides strategic regulatory advice and review of submissions made to worldwide Health Authorities, as well as regulatory assessment of changes for assigned products.
- You provide strategic and timely input to responses to questions and issues raised by Health Authorities during their review of these submissions.
- Responsibilities will also include interaction with worldwide Health Authorities.
- This position will be a flexible resource and may be used for other CMC RA Regulatory roles (both large and small molecule) as needed.
- You will stay abreast of all pertinent global laws, regulations and guidances to provide input on regional regulatory strategies and implementation activities.
- Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
- A minimum of a Bachelor's degree and 6 or more years of relevant pharmaceutical industry experience within chemistry pharmacy disciplines or related, OR an advanced degree (MS, PhD, etc.) and a minimum of 4 or more relevant experience is required.
- CMC regulatory or CMC experience is preferred. Basic knowledge of regulatory requirements is required.
- Drug development experience is preferred. Working knowledge of global HA laws, regulations, and guidances is required.
- Experience developing regulatory strategies and an understanding of product development is preferred.
- Solid understanding of biology and chemistry is preferred.
- Demonstrated ability to communicate regulatory requirements is required.
- Excellent interpersonal, teamwork, and verbal/written communication skills will be needed.
- Good organizational skills and the ability to manage multiple tasks/projects/priorities and complex systems simultaneously will be needed.
- The ability to communicate cross-functionally and cross-company as well as present and defend CMC management-approved regulatory strategy to corporate project teams is necessary.
- 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.