The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of regulatory strategy and submission timelines. • Manage document and submission preparation and timelines for regulatory submissions to the FDA, including INDs, DSURs, briefing documents, amendments, etc. • Interface with external Regulatory Operations vendor to support submissions to FDA. • Manage, track, and file all required SAE reports to FDA in accordance with Agency guidelines. • Liaise with CRO in the compilation of documents for ex-US health authority submissions including IMPDs, CTAs, amendments, aggregate safety reporting, and annual updates. • Interpret and communicate regulatory guidance to internal stakeholders to execute program objectives in compliance with applicable regulations. • Participate in cross-functional sub-teams focused on the execution of regulatory strategy. • Contribute to the development of department policies, procedures (RA SOPs), and best practices commensurate with the requirements of a rapidly growing company. • Acquire and manage regulatory intelligence, liaise with regulatory intelligence external vendors (as needed), and communicate information to key stakeholders. • Assist in the setup, management, and maintenance of the regulatory information management system (RIMS) and support the Quality function with the implementation of a new quality management system (QMS).
Essential Job Functions: • Excellent people skills, and experience developing strategic, and long-term relationships with key stakeholders. • Strong organizational, problem-solving, and analytical skills, as well as the ability to multi-task. • Demonstrated ability to clearly communicate the status of work, issues that arise, and proposed solutions to challenges to manager, team members, and head of the department. • Attention to detail and the ability to work individually, within a multidisciplinary team, and with external parties. • Strong team player who has a customer service approach and is solution oriented. • Ability to work in a fast-paced environment and meet aggressive timelines. • Strong written and verbal communication skills, including some regulatory writing experience. • Advanced knowledge of the Microsoft suite of tools including Word, Adobe, PowerPoint, Excel is required. • Previous RIMS experience is a plus.
Qualifications: • BS or MS with at least 4 years of direct experience in Regulatory Affairs in the pharmaceutical/biotech industry. • Strong knowledge of FDA regulations is required. • An understanding of ICH, EU and other rest of world (ROW) regulatory requirements is preferred. • Experience in managing the preparation of regulatory documents including individual modules of a new IND, Investigator Brochures, DSURs, IMPDs, CTAs, Orphan Drug applications, briefing packages and other regulatory submissions, in eCTD format. • Experience with small molecule drug development is preferred. • Experience with early development programs is a plus. • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience. • Knowledge of GMP, GLP and GCP regulations and clear understanding of the pharmaceutical product life cycle. • A three-day per week onsite presence is required for effective team interaction.