Regular, Full-time, Exempt
||Reports to the President with the primary responsibility to lead the North America Regulatory Affairs in developing regulatory strategies, providing regulatory strategic advice on advertising/promotion and medical materials.
|Essential Duties and
(Include but not limited to
Other duties may be assigned)
- Lead and prepare the Company in US regulatory affairs activities for new product under Subpart H.
- Develop and implement regulatory strategies and provide guidance on US regulation and marketing authorization requirements to project team members.
- Lead and manage cross-functional promotional review (MLR) committee meetings.
- Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the launch materials concerning disease awareness and promotional materials.
- Responsible for label negotiation with regulatory authorities.
- Build and manage meeting agendas as a partner to Marketing and facilitate meetings while memorializing MLR Reviewer comments.
- Responsible in dealing with participants of varying levels and experience, and able to steer productive meeting discussions to ensure regulatory compliance of materials generated for an anticipated US product launch.
- Work with Medical, Legal and Compliance, Commercial, in preparing and reviewing SOPs and policies relating to review and approval promotional and non-promotional materials.
- Enable best practices and SOP conformance. Use experience and judgment to identify jobs that may not be consistent with best practices, company policies or FDA guidance.
- Ensures that all SOP requirements are met.
- Provides guidance and training as required to all MLR participants.
- Attends MRC materials as needed.
- Create system for FDA Form 2253 submission and implement the same.
- Provides product development and label development strategies, as needed, to ensure promotional claims can be supported.
- Proactively identify regulatory issues and areas that may require revision or additional documentation.
- Provides expert guidance to help evaluate and mitigate potential risk. Offers creative solutions and strategies, including risk mitigation strategies.
- Partner with Legal and Compliance in providing guidance or training to teams regarding the review of promotional and non-promotional materials.
- Perform other tasks as necessary and/or required to ensure regulatory compliance while effectively managing business risks.
- Solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals.
- Experience interfacing with government regulatory agencies.
- Experience developing and implementing successful global regulatory strategies.
- Advance understanding of pharmaceutical development.
- Strong negotiation skills, and business acumen.
- Maintains professional decorum in all interactions with internal and external colleagues.
- Must be able to provide creative solutions to problems.
- Must have strong interpersonal and communication skills.
- Exhibits strong conflict-resolution skills.
- Must be able to work effectively in a multi-disciplinary and multi-cultural, global team environment.
- BS Degree or equivalent. Advanced degree desirable (MS, PhD, PharmD, or JD).
- Minimum 10 years regulatory experience in drug promotion/advertising and US labeling.
- Therapeutic area experience in rare disease is preferred.