This position is integral to assuring the Company’s commercial regulatory requirements and compliance with all applicable regulations and guidances. This position is responsible for decision-making, direction and oversight of commercial regulatory issues in order to meet internal and external customer needs.
Primary responsibilities include the following. Other duties may be assigned.
- Provide commercial regulatory knowledge, consultation, advice and risk assessments to the US organization, including senior leadership, that are aligned with corporate commercialization efforts.
- Collaborate with SSF cross functional teams, Field Sales team, as well as global teams in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives.
- Work with cross functional teams to enhance systems, technology and processes.
- Represent Regulatory Affairs as a member and Chair of the Actelion Review Committee (ARC). Provides guidance to members of the ARC regarding the current regulatory environment and regulatory considerations that may impact business activities.
- Provide regulatory oversight and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, institutional promotion, disease education, press releases, websites, speaker presentations).
- Provide regulatory guidance to the Medical Review Committee (MRC)
- Develop and refine consistent regulatory strategies for advertising and promotional of multiple marketed products; ensuring that labeling, promotion, and advertising materials conform to regulations, guidances and the law.
- Ensure Actelion’s regulatory processes are compliant with federal regulations pertaining to Subpart H, 2253, regulatory and risk management requirements.
- Provide direction and supervision to assure quality and timely submission (including electronic submission) of advertising and promotional materials to FDA in accordance with business objectives.
- Coordinate and lead communication with the relevant personnel at the FDA/OPDP to ensure successful interactions with the agency build a rapport and track evolving regulatory developments that impact the conduct of our business and inform senior management as appropriate.
- Identify potential areas of regulatory compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.
- Ensure quality documents are defined, created, maintained and implemented globally in accordance with Actelion requirements. In addition, provide local input on global SOPs as appropriate.
- Coordinate corporate wide on-going regulatory training to SSF office, field colleagues, medical congress booth staff, as well as speakers and vendors on regulatory issues pertaining to promotion of Actelion products.
- Regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement activities, and evaluate the impact on the industry and the company.
- Lead development of Commercial Regulatory strategies, policies, cross-functional projects, and interdepartmental decision-making.
- Train and mentor Regulatory Affairs staff.
- Act as liaison for temporary/contract workers.