Support the success of the US business through regulatory activities which include providing strategic regulatory advice on advertising and promotion materials and activities for assigned products in accordance with business goals and objectives and FDA regulations/guidance
- Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of all advertising, promotions and other related materials for assigned products to ensure compliance with applicable FDA laws, regulations and guidance.
- Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
- Serves as the primary regulatory reviewer for assigned products on the Legal/Medical/ Regulatory (LMR) committee and provides strategic regulatory guidance to Medical Affairs on relevant non-promotional activities.
- Ensures regulatory compliance while effectively managing business risks.
- Provides US regulatory input into sales and marketing initiatives and program plans for marketed products in line with commercial and company strategy, consulting with appropriate departments where necessary.
- Understands global promotional strategies and applies regulatory and therapeutic area knowledge to commercial Franchise Team's objectives and initiatives to develop solutions to complex US promotional issues
- Monitors US regulatory promotional environment and stays abreast of all relevant regulatory and industry changes and updates related to FDA guidance, warning letters, enforcement actions and regulations; and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes.
- Liaison with OPDP regarding advertising and promotion issues for assigned products. Establishes strong and positive working relationship with OPDP reviewers. Manages OPDP queries on assigned products. Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation.
- Participate on Regulatory Affairs Functional Teams and provide input to Global Regulatory Strategy Document, target product profile (TPP), clinical trial designs (pre and post marketing), in- and out-licensing activities with regard to ability to promote potential data/claims.
- Participate in US labeling negotiations as necessary and provides strategic regulatory guidance on the development of draft labels (based on global development plans and commercial strategic objectives), to insure that regulatory strategy will result in commercially viable US labeling upon which future promotion and advertising will be based.
- Review and approve regulatory content of product packaging artwork.
- Create and review relevant SOPs and Ensure all essential regulatory processes are written, incorporated into and controlled by the Kyowa Kirin Quality Assurance system.
- Provide relevant compliance training to staff from a regulatory perspective.
Obtain costings for regulatory activities and input into budgetary discussions.
- Line management of staff where direct reports assigned.
- Life science qualification with a minimum of 8 years of experience in regulatory affairs in the pharmaceutical industry.
- Expert regulatory knowledge with specific experience in promotional material review including therapeutic area knowledge in areas such as oncology, CNS, inflammation, bone disease and nephrology.
- Prior experience of directly communication with the FDA.
- 10% minimum travel required.
Key Competencies specific to the role
- Excellent negotiation, verbal and written communication and interpersonal skills.
- Good analytical and problem solving skills.
- Good organizational and project management skills and attention to detail.
- Ability to understand and present complex scientific arguments.