Director, Associate Director, Labeling - Boyle & Associates

Position Description

This position reports to the Sr. Director of Promotional Compliance and Labeling. This key position is primarily responsible for the global labeling activities associated with products. The incumbent will have primary responsibility for interactions and negotiations with DDMAC, and preparation of FDA and other Health Authorities’ labeling submission documents. Additionally, this position will chair cross-functional teams in the development of text and review of Core Data Sheets, USPI label and labeling revisions, Medication Guide, and SmPC label and labeling revisions. This position requires providing sound regulatory guidance to Clinical, Medical Affairs, Legal, Corporate Compliance and Commercial colleagues in regards to labeling activities. An important and critical role will be to represent the Regulatory Affairs Department at Medical Review Committee (MRC) and Promotional Review Committee (PRC) meetings, by being a proactive and effective communicator. It is imperative that this incumbent stays abreast of the most recent regulations and practices, and effectively communicates this information to colleagues.

This individual will hold accountability for overseeing all submissions to FDA regarding promotional and advertising concerns and labeling changes, while ensuring proper record and documentation maintenance within company. This will require the management of internal and external activities to assure the prompt provision of information necessary for such submissions according to designated timelines. This individual will have a sound working knowledge of FDA’s position on labeling, promotional and advertising activities and a through understanding of FDA enforcement actions (i.e, Untitled Letters, Warning Letters). In addition, responsibilities include: p>

Assumes a leadership role for interactions and negotiations with DDMAC at FDA.

Serves as Regulatory Affairs representative to assigned project teams/committees and proactively interacts within company’s functional areas, corporate partners, and, contract manufacturers in order to achieve common goals.

Maintain excellent working relationships with the FDA, other Health Authorities, Project team members, collaborators/partners and contract manufacturers

How to Apply

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