At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Position Summary: MannKind Corporation is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs. Reporting to MannKind’s Chief Medical Officer, this position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. They will be a key member of the project leadership teams and will help to inform the design and execution of clinical trials, as well as manage all regulatory submissions for the company. This individual will direct and coordinate activities in regulatory and work with the executive team in formulating strategy, enhancing performance, and administering relevant policies around this critical functional area. S/he will provide strategic leadership and key insights that will allow the organization to operate collaboratively and proactively, interacting closely with internal peers and externally with FDA, EMA, and other key stakeholders. This position has the responsibility for tracking trends and requirements in the global market and the impact that the changes will have on the company’s portfolio. They will also be responsible for analyzing and evaluating the company’s regulatory procedures to ensure the attainment of financial and strategic goals. This includes ensuring that all corporate regulatory goals are clearly defined, met, and are in compliance with all current industry standards globally.
S/he must be adept at formulating and driving strategy, and also be tactically oriented, preparing and writing submissions and playing a hands-on role in regulatory submissions. Furthermore, this individual will have demonstrated an ability to partner effectively with multiple functions, including Clinical, Research, Development, Medical Affairs and Quality. At a personal level, the company is seeking a highly motivated individual who thrives on being challenged and working in highly collaborative environments to contribute to their cutting-edge science. Strong interpersonal skills are necessary, as this individual will serve as a voice for the company internally as a trusted member of the team. A proven ability to communicate with other members of the executive management team, Board members, external thought leaders, and research and development staff in a fast-paced environment is crucial. Furthermore, the capacity for strategic thinking is highly important. In short, outstanding leadership and management skills with rigorous scientific intellect and standards and understanding of the business aspects of drug development are required. Finally, an ability to think and manage strategically, with an attention to detail is needed, as is a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.
Principal responsibilities: - Collaborate with Clinical Team to develop and implement the US and global regulatory affairs plan across product portfolio
- Oversee development and refinement of regulatory policies, procedures, and SOPs
- Work closely with commercial, clinical development and Medical Affairs in designing and implementing launch strategies and tactics, and life cycle planning
- Provide regulatory assessments of product opportunities and threats
- Provide regulatory expertise in the development and approval of promotional materials
- Collaborate with Commercial, Legal, and Clinical for development and review of labeling, advertising and promotional materials
- Lead, develop, mentor and manage the Regulatory Affairs team
- Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to maintain a compliant culture
- Anticipate global regulatory changes and develop proactive strategies accordingly
- Provide strategic guidance to drug development on all aspects of regulatory requirements
- Interpret FDA (and other regulatory body) communications, expectations, and decisions to internal and external stakeholders, developing and implementing successful issue resolution strategies
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
- Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
- Develop and plan innovative regulatory strategies for label enhancements and life cycle product management
- Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
- Provide review and approval of all external-facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations
- Assess project plans and timelines and ensures all projects are appropriately prioritized and key goals are met on time
- Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
- Establish, maintain, direct and communicate a global benefit-risk strategy for each pre-market, marketed and future MannKind product that includes risk management and minimization
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
Education and Experience Qualifications: - Bachelor’s degree in a scientific discipline; Graduate degree (Ph.D. or PharmD) strongly preferred
- Progressive related experience in regulatory affairs in the pharmaceutical/biotech industry
- Experience with designing and executing creative regulatory strategies for innovative products
- Must have a solid understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug promotional and development processes
- Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial
- Experience with clinical trials and regulatory documentation is required
- Experience with inhalation products, biologics preferred
- Experience with post-approval change management, comparability assessment, post-marketing commitments, and overall product life cycle management
- Excellent organizational, written and verbal communications, project and time management skills needed to drive multiple ongoing projects simultaneously
- Results-driven and team-oriented with the ability to influence outcomes
- Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner
- Must be able and willing to work diligently in a high-visibility, fast-paced environment with changing timelines and priorities and exhibit a passion for patients
- Willing to travel up to 15%
#J-18808-Ljbffr
