United States onlySumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Regulatory Advertising & Promotion. The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regulatory reviewer for assigned products. This position is responsible for providing strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives. This position may train/mentor junior staff and/or oversee external consultants.
This position works with a high level of autonomy and requires limited coaching and mentoring.
Advertising & Promotion Review Activities
- Review and approve materials that comply with relevant external advertising & promotional regulations or codes of practice (e.g., FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding principles.
- Align with regulatory colleagues on strategies to optimize the commercial success of products for clinical trials, labeling, etc.
- Develop and maintain productive working relationships with colleagues and vendors contributing to development, review, and approval of promotional materials, e.g. Marketing and their Agencies, Legal, Compliance, and Medical Affairs.
- Provide appropriate oversight of promotional material review and ensure on-time and accurate submission of applicable materials to regulatory agencies.
- Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA.
- Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion of prescription therapies.
- May be responsible for creating and reviewing SOPs and department operating procedures.
Manage and Develop Talent
- May train/mentor junior staff and/or oversee external consultants.
Key Core Competencies
- Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills with the ability to influence others, internally and externally, in a positive and effective manner.
- Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values.
- Ability to work in a diverse environment.
- Ability to prioritize tasks and work across locations and time zones.
- Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization.
- Demonstrated track record of leading promotional copy review and approval team and of successful interactions with OPDP staff and management.
- Sense of urgency and perseverance to achieve results.
- Capable of effectively negotiating with others while maintaining composure.
- Ability to learn new therapeutic areas when necessary.
- Ability to make complex decisions and willingness to defend difficult positions.
- Comfortable presenting to all levels of the organization including Senior Management.
Education and Experience
- 8 – 12 years experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory advertising & promotion.
- Advanced degree preferred (preferably in a scientific discipline).
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Japan