Vice President, Global Regulatory Affairs

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary

The VP, Global Regulatory Affairs is responsible for the management, development, implementation and coordination of the regulatory affairs organization. The individual will oversee the regulatory affairs department and be responsible for providing global regulatory strategy and ensure timely completion of regulatory activities and deliverables. They will need to ensure that all regulatory activities for development and marketed products are achieved according to agreed schedules, budgets and company objectives. The candidate will provide senior level regulatory expertise and leadership for the organization, company, customers and external third parties. The individual will have responsibility for overseeing and implementing regulatory process. They will lead the coordination of all regulatory submissions and interactions in a manner that instills confidence and trust among the regulatory authorities.

This leader will facilitate the development of a cohesive Regulatory Affairs strategy and direction through effective optimization and integration of all groups internally and externally. They will provide regulatory affairs counsel to internal stakeholders, maintain the regulatory dialogue with the US FDA as well as ex-USA authorities, and interact with internal teams and external vendors in support of regulatory filings and clinical development activities in the US, EMEA, China, and Japan.

Job Requirements

Education and Experience

• Global regulatory experience across EMEA, China, and Japan required.
• BA/BS degree required, preferably in a health/life sciences or related field.
• Minimum 15 years of industry experience with increasing responsibilities in regulatory affairs is required
• Prior Experience with CMC Regulatory including IND/ required
• Demonstrated experience leading multiple NDA filings
• Extensive experience interacting and leading meetings with the FDA
• Proven experience and knowledge in leading and executing in bio-pharma and/or pharma organizations
• RAC or similar certification strongly preferred
• A strong understanding of regulatory authority guidance, including ICH
• Rare disease experience is preferred
• Respiratory therapeutic experience preferred
• Experience presenting to Board Members and Investors preferred
• Demonstrated people leader
• Prior experience leading a team responsible for life cyclic regulatory requirements post approval strongly preferred
• Business travel 10-20% as required
  
  

Knowledge, Skills and Abilities

• Previous experience with regulatory filings and interactions with US FDA medical divisions and EU EMA/CTA filings
• Recognized internally and externally as an expert in regulations, guidelines and precedents related to clinical and pharmaceutical development, labeling and promotion
• Substantial knowledge and experience with regulatory affairs and regulations; demonstrated ability to develop and maintain excellent working relationships with regulatory authorities
• Demonstrates current knowledge of global regulatory changes and impacts to the market
• Experience appearing before regulatory agencies and health authorities with the demonstrated ability to interact and present effectively, to anticipate and respond to questions and to report back to senior management and colleagues
• Clinical intelligence and understanding sufficient to interact and communicate at a scientific level in discussions; highly attuned on the clinical side with the ability to manage and even advise, as appropriate
• Outstanding record of managing and integrating the programs of entire function within the Regulatory Affairs department
• Compelling interpersonal verbal, written and presentation skills in communication with internal and external customers
• Demonstrated business management experience and understanding coupled with the ability to enable successfully, simplifying the complex to drive alignment and understanding amongst various parts of the organization
• Demonstrated experience hiring, leading, and developing regulatory team members and enabling high performing regulatory teams
• Strong management and organizational skills with an ability to prioritize and enable and accelerate multiple programs and projects
• Able to communicate, influence, inspire, learn and teach horizontally and vertically within a multi-disciplined highly-matrixed organization
• Proven agility and success in a dynamic company / business environment where change is frequent and rapid understanding and alignment is paramount
• Demonstrated aptitude for ‘hands-on’ troubleshooting and problem solving with an exemplary history as a “self-starter”
• Strong desire to work as part of many cross-functional teams consisting technical, scientific and administrative team members
• Proven ability to lead organizational change
  
  

Job Responsibilities

• Act as primary regulatory contact and strategist with the FDA, international regulatory agencies and other regulatory bodies.
• Provide innovative regulatory approaches and oversight in the development of Liquidia’s portfolio from IND or equivalent to filing and approval.
• Provide regulatory oversight for product development, manufacturing and commercial operations.
• Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
• Monitor the US and international regulatory environments and provide Senior Management with assessments of the impact of new and changing regulations on the company’s business.
• Develop and implement training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulation.
• Coordinate the review and approval of product labeling and advertising.
• Review and interpret regulatory rules and ensure that they are communicated through company policies and procedures.
• Identify issues early in the submission process that could potentially impact product launch.
• Determine submission requirements and coordinate plans and timelines with Project Management.
• Contribute, review and approve clinical strategies and protocols.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approvals.
• Contribute and in some instances lead the creation and review of regulatory documents, including Premarket approvals applications, clinical study protocols/data and CMC.
• Reviews marketing materials and claims to ensure compliance with regulatory requirements.
• Support Technical filings for ROW Registrations.
• Monitors regulatory outcomes of initial product concepts and provides input and advice to Senior Management Team.
• Provide regulatory review and advice on business development opportunities including regulatory due diligence.
• Reviews and advises on international product registration requirements, making recommendations to management regarding regulatory process and strategies.
• Supports the organization on regulatory matters, complaints, potential recall concerns or any other regulatory related situation.
  
  

Benefits

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note :

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.