Director, Regulatory Affairs, Advertising and Promotion

Job description

Reporting to the Vice President, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information for assigned Alkermes products and disease areas. Partners with other personnel in Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of brand initiatives and review of external communications materials. Develops and maintains positive working relationships within and across departments in relation to promotional issues. Communicates with FDA and contributes to health authority negotiations as necessary. This is a hybrid position, onsite at our Waltham, MA office. Skills: - Provide oversight and review of product and disease state education materials for consistency with approved labeling and alignment with applicable FDA regulations and guidances. Provide strategic support to the business and alternative solutions to challenges in order to achieve desired outcomes. - Member of multi-disciplinary teams such as Copy Clearance Committee, Global Regulatory Team, Labeling Team; chairperson for...