p>Responsibilities: • Provide regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area • Provide solution oriented and innovative advice to meet the Companys objectives and goals • Provide strategic advice for the development of Promotion advisory submissions • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidance • Continuously monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice • Pursues and understands diverse perspectives inside and outside Sun Pharma to provide risk assessment and mitigation strategies • Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Legal and Compliance • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues • Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based • Provide input on process improvement as needed • Engages with colleagues within the department to help support them in their roles and development • Provide direct management to individuals depending on assignment • Proactively seeks opportunities to learn and develop leadership skills.
Education & Qualifications:
Education Required: Advanced degree (MS, PhD, PharmD, or JD) Minimum of 5-10 years Regulatory promotional review or 8 to 10 years of related pharmaceutical experience (e.g., Medical promotional review) Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s) Strong understanding of FDA regulations (OPDP/CBER) Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns Proven aptitude to analyze and interpret efficacy and safety data Represents Ad/Promo at labeling meetings and provides strategic regulatory guidance Organizational skills and ability to pay attention to details Demonstrated ability to negotiate and influence others to help build team collaboration Excellent verbal, communication, and presentation skills Manage, oversee, and review the work of one or more direct reports Mentors Ad/Promo and cross-functional team members as needed.