Senior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - Hybrid
$243k - $297kJobRx, Inc.
Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients. As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well‑being. Reaching People. Touching Lives. Job Summary Sun is seeking a Senior Director, Regulatory Advertising and Promotion within its Medical Affairs in Princeton, NJ. This role will report to the Head of Medical Affairs. The Senior Director will apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area to help ensure the Company’s objectives are met. The role ensures materials are consistent with Sun Pharmaceuticals policies and procedures, while enabling the business to compliantly meet its goals and objectives. Excellent interpersonal skills, flexibility, and adaptability to a changing environment are required, as well as the ability to communicate effectively with cross‑functional teams and business partners across the company. 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 the assigned product/therapeutic area. Provide solution‑oriented and innovative advice to meet the Company’s 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. Pursue and understand 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. Engage with colleagues within the department to help support them in their roles and development. Provide direct management to individuals as required by the assignment. Proactively seek opportunities to learn and develop leadership skills. Education & Qualifications Advanced degree (MS, PhD, PharmD, or JD) required. Minimum of 5-10 years Regulatory promotional review or 8-10 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. 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 attention to detail; demonstrated ability to negotiate and influence others to build team collaboration. Excellent verbal, communication, and presentation skills. Manage, oversee, and review the work of one or more direct reports. Mentor Ad/Promo and cross‑functional team members as needed. Compensation and Benefits The presently‑anticipated base compensation pay range for this position is $243,000 to $297,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. This position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the employee will be in an "at‑will" position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. #J-18808-Ljbffr
$258.68k - $313.46k
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