The Associate Director, Regulatory Affairs will be responsible for the regulatory review and approval of all labeling, based on development and management of a target product profile (TPP).  They will oversee and coordinate the regulatory review and approval of all commercial materials through the Promotional Review Committee (PRC) and interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products. In addition, this position oversees all regulatory operational management of commercial materials (Veeva Vault – electronic document management system, applicable processes and SOPs and will work with regulatory operations for the submission of all materials to FDA.

Key job duties and responsibilities are as outlined below – and will included providing strategic advice on advertising and promotional activities for assigned products in accordance with business goals and objectives, FDA regulations/guidelines, PhRMA guidelines and company policy.  Informs teams for assigned products and projects on implementation of compliant product labeling and communications. This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance based on internal and external guidelines. 

Principal Responsibilities:

• Review and approve product labeling (including all advertising and promotional materials) and participation in design reviews to ensure adherence to regulatory requirements as set forth in the CFRs.
• Develop, implement, and maintain procedures in support of regulatory compliance.
• Develop and manage TPPs for products, working with cross-functional disciplines.
• Assist with the development and implementation of regulatory labeling strategies for existing, new and modified products.
• Provide review and approval of product and process changes, as required, to ensure compliance with regulatory requirements.
• Assist in developing and documenting sound regulatory decisions and justifications and advising organization on impact of changing regulations. Interpret product, policy and process changes to ensure compliance with regulatory requirements.
• Assist with the creation and maintenance of regulatory documents and claims, and up-to-date (regulatory changes, business changes, new indications) labeling for products.
• Review and approval of labeling and marketing collateral to ensure substantiation of claims, adequate information, and cautions/warnings are present and that all labeling is in conformance to regulatory requirements in accordance with Federal, state, and other applicable regulatory and quality requirements.
• Provide regulatory guidance, respective to labeling, to product core teams developing new products.
• Works with Regulatory Leadership as company representatives with FDA, European Authorized Representative and other regulatory agencies to obtain approvals as required.
• Interface with regulators through the submission process, through industry associations and other forums to ensure corporate awareness of critical path requirements.
• Oversee or manage interactions with OPDP regarding advertising and promotion for assigned products. Establishes strong and positive working relationship with OPDP reviewers.
• Applies regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks.
• Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission).
• Develop regulatory plans including rationale and internal documentation for non-filing decisions.
• Provide promotion integrity advice and guidance on the development of the draft labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based.
• Participates in US labeling negotiations and FDA meetings as necessary.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
• Understands global promotional strategies and provides solution to local US regulatory promotional issues.
• Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major PhRMA, FDLI, DIA and other industry/FDA meetings.
• Oversee operational processes and procedures related to the review/approval of materials with the purpose of promoting, advertising or providing information about the Company and the Company's products.
• Provide educational training for local regulatory staff, sales teams, contractors and others regarding company policies and procedures within the scope of the Regulatory Affairs Advertising, Promotion.
• Candidate to assist with additional regulatory projects as needed.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.