Manager of Regulatory Affairs, Global Submissions

Manager of Regulatory Affairs, Global Submissions

For our rapidly growing facility in Rockville, Maryland, we are seeking a bright, professional, personable, and dependable addition to our team.

Manager of Regulatory Affairs, Global Submissions

Your major tasks will be:

• Working with global team members on Clinical Trial Applications, Investigational New Drug (IND) Applications, Biologic License Application (BLA), Marketing Authorization Application (MAA) including compilations, submissions, tracking and archiving.
• Responsible for liaising with internal and external cross-functional study team members to ensure proper documentation of key submissions and for keeping timelines for submissions.
• Responsible for managing global submissions and the compilation of Regulatory documentation for submission. This includes working closely with the Regulatory Strategy Team (content review) to ensure that the submissions content is reviewed prior to submission and that all documentation is present and meets regulatory requirements. This includes generation of Submission Outlines/Table of Contents. This role is also responsible for the assembly of electronic and paper submissions, including steps to create submission ready electronic documents. This includes formatting, editing, PDF checks, copying, binding, and shipping activities, as needed.
• Quality control of regulatory documents, both electronic and paper, to ensure compliance with Company and Agency requirements. Responsible for archiving, indexing, and filing of regulatory documents in both paper and electronic systems, as per the archival procedures and workflows. Responsible for creating and maintaining the submission reference library.
• Provide documentation support within Regulatory Affairs for all Due Diligence activities.
• Ability to handle multi-tasking, multiple-projects and work with a team located in Europe.



Requirements:

Your profile:

• Advanced experience in desktop applications, Microsoft Office Suite, ISI Writer, Adobe Acrobat, MS Project.
• Experience in indexing Regulatory Affairs documents.
• Expert knowledge of the eCTD including the publishing aspects as well as the content required for major submissions.
• Advanced experience with regional regulations especially the European Union and the United States, but also Rest of World.
• Strong communication and organizational skills and the ability to multitask.

The offer:

• The successful candidate will have the unique opportunity to work for and gain experience in an international company with a dynamic and collegial environment.
• The successful candidate will be given interesting tasks with opportunities for personal initiative and professional growth.
• The compensation and benefits will be market competitive and commensurate with experience.


Micromet is a bio-pharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE® technology, as well as conventional monoclonal antibodies. Three of Micromet's BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Sanofi-Aventis, Bayer Schering Pharma, Merck Serono, Boehringer Ingelheim, MedImmune, Nycomed and Amgen. Micromet's corporate headquarters are located in Rockville, Maryland, and its Research and Development facility is located in Munich, Germany.