Senior Manager Regulatory Affairs Advertising and Promotions
Aadi Bioscience Inc
Type: Full Time
Required Education: 4 Year Degree
Salary + Bonus
Telecommuting is allowed.
Internal Number: 334204
The Senior Manager of Regulatory Advertising and Promotions reports to the Executive Director of Regulatory Affairs and will manage the development and review of advertising and promotional information of the company’s marketed products. This position will also have an opportunity to provide regulatory support to clinical and non-clinical regulatory activities as needed.
PRIMARY JOB FUNCTIONS
Serves as a regulatory advertising and promotion reviewer on cross-functional Promotional Review Committee (PRC) and Medical Review Committees (MRCs)
Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks
Identifies and provides guidance on the development and improvement of policies, processes, and standards for promotional materials and related activities
Maintains a deep and current awareness of evolving FDA and OPDP regulations and interpretations, advisory comments, enforcement actions and policy issues;
Effectively partners with Medical Affairs, Legal Compliance, Commercial and International Distributors, as needed, to ensure promotional labeling, advertisements and educational materials are reviewed in a timely fashion throughout the product life-cycle
Assists Commercial with the planning and prioritization of proposed promotional and disease state materials; provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved
In collaboration with global regulatory operations, ensures the management and maintenance of records and databases that support communication with OPDP
Delivers Regulatory compliance training to assigned teams in preparation for scientific conferences on and off-site
Identifies and escalates any unresolved regulatory affairs compliance concerns
Provides oversight to relevant external vendors and consultants
ESSENTIAL QUALIFICATIONS AND SKILLS
Must have knowledge and experience in global drug development, global regulations and guidelines and GXPs
5 or more years of experience in advertising and promotions in a drug development environment
Experience and knowledge in oncology, cardiovascular disease, neurological and metabolic diseases strongly preferred
Ability to work collaboratively and productively in a diverse, continually changing and team-oriented organization
Ability to work independently with internal and external stakeholders at various levels
Excellent organizational, facilitation and communication skills
Self-motivated and able to work from a home office environment
Demonstrated leadership capabilities and proactive problem-solver
Practical knowledge of MS Word, Excel, PowerPoint, and project management software
This role can be performed remotely from a home office in the US.
Some long-distance travel (10%) may be required with a potential of travel occurring over weekends.
Flexible approach to time management with occasional work in evenings or over weekends as required.
ABOUT OUR CULTURE
We believe in thinking big without compromising attention to detail, being graceful under pressure, and being unafraid to roll up our sleeves to get things moving. A collaborative mindset, natural curiosity, and humble attitude are critical to our corporate culture and the key to our success.
ABOUT AADI BIOSCIENCE
Aadi Bioscience Inc. (Aadi) is a rapidly growing biopharmaceutical company focused on developing and commercializing precision medicines targeted to rare genomic alteration-driven cancers. Aadi’s leading asset, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension), targets cancers driven by mTOR pathway activation, including advanced malignant PEComa, a rare type of sarcoma, and TSC1/2 alterations in a tumor-agnostic setting. Aadi is poised to take its precision medicine approach to market with the support of a world-class team that shares its deep passion for scientific innovation and commitment to improving patient outcomes in rare oncological disorders.
Aadi Bioscience is proud to be an Equal Employment Opportunity employer committed to a diverse and dynamic workplace. We do not discriminate based upon race, reli...gion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.