Biotechnology, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
The Director of Regulatory Affairs will oversee and direct the development and implementation of regulatory strategies for Alder Biopharmaceuticals development programs. Individual will also be responsible for preparation and submission of regulatory documentation to health authorities and direct interaction with regulatory authorities. The incumbent will ensure that all necessary applications are filed and will represent Alder with government agencies.
Specific responsibilities will include:
Develop and execute effective regulatory strategies and plans.
Represent Regulatory Affairs on cross-functional teams, providing regulatory affairs strategy and support for assigned programs.
Identify and assess regulatory risks regarding regulatory requirements and strategies.
Maintain proactive/current awareness of regulations and guidelines pertaining to all aspects of programs.
Coordinate and lead communication with the relevant personnel at the FDA to ensure successful interactions with the agency.
Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials.
Plan and lead meetings with Regulatory Authorities including background documents and action plan following such meetings.
Oversee submission build, compilation and publishing activities associated with generating hard copy and electronic submissions
Maintain US and ex-US submission files and logs.
Manage Regulatory Affairs staff.
Bachelor’s degree in related field required; advanced degree preferred (or relevant experience).
Minimum 10 years’ experience in regulatory affairs in drug/biologic development.
Direct experience with FDA required and international experience preferred.
Solid understanding of dossier requirements New Drug Application (NDA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA).
Experience with effective project team leadership and management oversight.
Highly organized with attention to detail.
Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills.
Internal Number: C18-158
About Alder BioPharmaceuticals
Alder BioPharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize genetically engineered therapeutic antibodies with the potential to meaningfully transform current treatment paradigms.
Alder’s lead pivotal-stage product candidate, eptinezumab, is being evaluated for migraine prevention. Eptinezumab is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), a protein that is active in mediating the initiation of migraine.
Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine.
Clazakizumab, Alder’s third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc.