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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Position Title: Senior Manager/Associate Director, Regulatory Affairs
Department: Regulatory Affairs
The Senior Manager/Associate Director, Regulatory Affairs will make significant contributions to the Regulatory Affairs Department by providing strategic guidance and tactical support to further the progress of assigned development programs, including participation and influentially contributing to regulatory strategy and operational meeting discussions. This role will also provide guidance to project teams on current regulatory guidance from FDA and/or other North American health authorities, which will ensure the added value to the business mission of the Company through facilitation of the registration and launch of development and approved medical products. This position reports the VP, Regulatory Affairs. Travel up to 10% may be required.
The primary responsibilities of this role include, but are not limited to:
Keep apprised of new regulatory developments in assigned geographic region
Demonstrate knowledge of Company Policies, Standard Operating Procedures and Working Practices within the corporate-required timeline
Implement regulatory strategies to support development and filings of INDs, CTAs, NDAs, MAAs and defense of those applications
Plan and oversee the preparation of regulatory applications for submission to the FDA
Review content for all regulatory submissions from other disciplines to ensure high quality and relevance for intended objectives
Develop and manage project timelines for assigned projects
Assess preparation requirements, including planning, writing and reviewing of development, regulatory (clinical and nonclinical) sections of regulatory submissions, including responses to regulatory requests
Work with CMC and Medical/Pharmacovigilance Colleagues for the regulatory requirements for Quality- and Safety-related business
Collaborate and/or communicate with other development and business/commercial lines within the company, as well as with external partner companies and outsourcing vendors, and Health Authorities
Maintain log of Records of Contact with health authorities, including correspondence
Support the development of product labeling for initial submission, as well as for labeling changes as the products progress in their life cycles, including updating of the Company Core Data Sheet
Participate in the development of post-marketing commitment/requirement strategies and track progress to fulfillment, as required
Compile and proof documents for submission
Training and Education
Bachelor's degree in a life sciences field required.
Minimum of 5 years in a pharmaceutical, biopharmaceutical, animal health or medical device organization working, including a Contract Research Organization (CRO) in a matrix environment, or equivalent experience in a governmental health-related regulatory agency, with at least 2 of those years in a strategic regulatory affairs role.
Up-to-date knowledge of regulatory guidelines and publications in the assigned region.
Direct experience with preparation and review of major and routine submissions in assigned region.