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Years of Experience
Date Last Verified
ProfileAssociate Director, Regulatory Affairs Duties: Performing or managing key regulatory activities for the department, including clinical trial support, safety reporting, labeling, and required filings such as IND and NDA annual reports. Working closely with functional areas and project teams to support further product development and global approval. Create and maintain regulatory timelines and track deliverables to timelines to ensure that regulatory submission timelines are met. Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on both development program and lifecycle opportunities. Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks. Develop and/or review regulatory documents to ensure that all submissions are of high quality. Provide critical review of documents (SOPs, protocols, and reports) related to clinical, drug safety, nonclinical or manufacturing, as necessary. Interface with functional areas (Clinical, Nonclinical, CMC, Commercial, Drug Safety) to identify and obtain information required for regulatory submissions. Manage IND/CTAs, NDA/MAA, annual reports, and information amendments in multiple countries for multiple protocols. Manage the preparation and filing of regulatory applications. Interface with global regulatory authorities and consultants as needed. Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages. Maintain knowledge of current global rules, regulations, and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area. Develop and maintain current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to others as needed. Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling. Facilitate Labeling Review Committee activities. Participate on Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.
Qualification and Experience
Requirements: BS or higher degree in science or law, or equivalent, with 7+ years of experience in Regulatory Affairs. Experience in preparation and submission of CTAs and amendments. Attention to detail with solid coordinating, task planning and time management skills. Experience in managing, mentoring and developing direct reports. Outstanding verbal, written and interpersonal communication skills. Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability. Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies. Thorough understanding of global drug development regulations and guidelines. Proven ability to successfully manage major submissions and critical projects to deadlines. Extended knowledge of science and data of assigned products and how that translates into labeling language. Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion. Strong communication and management skills are required. Knowledge of U.S. and international regulations and guidance governing drugs in all phases of development.